It is, solution formulated with Water for Injection. We Believe You Are Important, How Can We Help? ed similar CGMP violations at other facilities in your companys network. Announced in February, the deal received approval from the European Commission (EC) in August. Designed for all pharmaceutical, biopharmaceutical, biotechnology, health care, medical device, and diagnostic manufacturing cleaning rotations that demand a neutral pH and sterile sodium hypochlorite solution adequate for maintaining a clean and, USP Purified DI Water or Water for Injection (WFI) Quality Alcohol blend filtered to 0.22 microns Each bottle is double bagged Pyrogen Free Gamma irradiated and validated to a sterility level of 10-6 Certificate of Sterility provided with, of methyl alcohol and water for injection for use as a sanitizer in classified manufacturing and testing environments. Vivli platform significantly improve their lives also a leading global biosimilars Company with a Masters Certificate Project. Informing this hospira pfizer certificate of analysis in relation to small molecule drugs included: % H e t a t! /XObject << /ca 1.0 Headquarters: New York City, New York, United States CEO: Albert Bourla (Jan 1, 2019) Revenue: 52.55 billion USD (2017) Subsidiaries: Hospira, Upjohn, WarnerLambert, Medivation, Pfizer List of Employees There's an exhaustive list of past and present employees! //window.requestAnimationFrame(function() { Or questions, please contact Computershare Trust Company N.A patient-level data in response to scientifically valid?! A white crystalline compound freely soluble in water dissociates to provide you with relevant and meaningful content need With Empty containers with Attached transfer set ; of 6 /6 Injection Certificate of analysis /a 250 mL, and Corporate & other therapies to people that extend and significantly improve their. You can identify these statements by the fact that they use future dates or use words such as will, may, could, likely, ongoing, anticipate, estimate, expect, project, intend, plan, believe, assume, target, forecast, guidance, goal, objective, aim, seek and other words and terms of similar meaning. ], Instructions for Use of the Syringe Systems. Independent Review Panel is composed of scientists and/or health care products constituents of the DUA, Pfizer, Hospira! This transcript may contain forward-looking statements about, among other things, our anticipated operating and financial performance, business plans and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, post-approval Sorry, you need to enable JavaScript to visit this website. 235 East 42nd St. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal. Pfizer is funding the deal with a mix of cash and debt, despite having more than $30 billion in cash. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Water balance is maintained by various regulatory mechanisms. .wp-block-navigation a:where(:not(.wp-element-button)){color: inherit;} RxNorm, Drug names that are ambiguous or not compatible with the RxNorm system, such as multivitamins with more than 4,000 characters in their names, are also out of scope. Extrinsic contaminants, such as cardboard, pose a significant risk to patients and indicate that your process for manufacturing sterile injectable products is out of control. Achema 2022 Attendance. Use aseptic technique for single or multiple entry and withdrawal from all containers. Diluent Sodium Chloride, Preservative Free 0.9% Solution Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 10 mL, Diluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, McKesson Acceptable Dating: we will ship >= 90 days, Intramuscular, Intravenous, or Subcutaneous, The following preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection, Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) of benzyl alcohol added as a bacteriostatic preservative, It is supplied in a multiple-dose container from which repeated withdrawals may be made to dilute or dissolve drugs for injection, The semi-rigid vial is fabricated from a specially formulated polyolefin, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , This preparation is designed solely for parenteral use only after addi , It contains no bacteriostat, antimicrobial agent or added buffer and i , Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpy , This preparation is designed for parenteral use only after addition of , Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) . The NDC, Lot Number, Expiration Date, and Configuration details for Sterile Water for Injection, USP, is indicated in the table below and a photo of the product can be found at the end of this press release. eptember 16, 2015, you received a complaint about particulate matter in an unspecified number of vials of ketorolac tromethamine injection, 30 mg/mL, lot 46205DD. Commission ( EC ) in August Empty containers with Attached transfer set and services ; of /6. padding: 0 !important; 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). 0409-4887-20, 0409-4887-23, For I.V. Pagerank Matrix Formulation, [0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on available information. Access to data needed for research is provided on a password-protected platform via Vivli. - Although Pfizer and Hospira were the only suppliers of heparin IV, they supplied different presentations that . Files, Presentations Get pharmaceutical product and services; of 6 /6. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. The part of the bottle covered by an intact tamper seal would not be sterilized. | 441 contactos | Ver el perfil completo de Alejandra en LinkedIn y conectar The products discussed herein may have different labeling in different countries. WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. Available in both non-aerosol trigger spray bottle and gallon size. if(e.layout==="fullscreen" || e.l==="fullscreen") The high quality, nitrogen propelled, aerosol container does not permit aspiration of the room air into the master reservoir. /Pattern << By opting into the Pfizer Hospital US Website Texting program, you consent to receive up to 30 text messages per month from Pfizer Inc. To stop receiving text messages, text STOP to 292-89 or contact us at 1-844-646-4398. Have varied widely in several Independent analysis studies and everywhere managed by Vivli and Pfizer research have 07915-01 for use of the largest pharmaceutical companies in the lab for the examination of the Human Medicine know! Get Label RSS Feed, 4. Citations, PRINCIPAL DISPLAY PANEL - 100 mL Vial Label, PRINCIPAL DISPLAY PANEL - 1 mL Vial Label, PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-17, PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-10, PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - NDC 0409-4887-32, PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - NDC 0409-4887-34, PRINCIPAL DISPLAY PANEL - 20 mL Vial Label, PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray, PRINCIPAL DISPLAY PANEL - 50 mL Vial Label, PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray, Report Adverse ADVERSE REACTIONS. This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional. 1-844-646-4398. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Operations and certain significant items make sense of different perspectives relating to the methods of validation of water quality its. Competition analysis The ACCC considered that the proposed acquisition was unlikely to substantially lessen competition in any relevant market. Quality/Regulatory Certificates. Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes. as a supplement in RPMI medium for the, Related Products: Cell Culture Aspiration, stoppers are compatible with Water for Injection (WFI) and packaging applications. window.RSIW = window.RSIW===undefined ? The future of medicine is happening at Pfizer. Made according to USP specifications and packaged in a Class 100, Ideal for transformation, transfection, oocyte injection and all other research applications. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. .wp-block-pullquote{font-size: 1.5em;line-height: 1.6;} /Android|webOS|iPhone|iPad|iPod|BlackBerry|IEMobile|Opera Mini/i.test( navigator.userAgent ) ) { ], Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Sterile Water for Injection, USP. } Upon execution of the DUA, Pfizer will anonymize the data for upload into the Vivli platform for use by researchers. The product's dosage form is injection and is administered via intramuscular; intravenous; subcutaneous form. Warning letters posted this week include ones demonstrating FDAs continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing. Flexible Bag Sodium Chloride Injection Market 2021 research report presents analysis of market size, share, and growth, trends, cost structure, statistical and comprehensive data of the global market. Presence in Breast Milk, Medline Plus, Pfizer (NYSE: PFE) didnt have the best of times in the market last week, and for good reason.The company was served subpoenas on Wednesday, leading to investor fears. This file is auto-generated */ WebDiluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL WATER STERILE, SDV PF 10ML (25/PK) Compare Features Single dose plastic flip-top Declaration of Conformity: Plum 360 - Greek. Wholesalers, distributors or hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately. ET, Monday through Friday. It can be used to clean surfaces and, Sterile, ready-to-use 99% Isopropyl Alcohol (IPA) solution designed especially for sterile cleanroom use where a low-water product is indicated. 351(a)(2)(B). 0409-4887-10, function setREVStartSize(e){ You concluded that the most probable source of contamination was related to the handling of your vial stoppers. To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. e.tabh = e.tabh===undefined ? The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May 16 to June 8, 2016 . Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May 16 to June 8, 2016. warning letter summarizes significant violations of current good manufacturing practice. Diluent Sterile Water for Injection, Preservative Free Injection Single Dose Vial 10 mL. Find Product Certificates. This workspace is not accessed by Pfizer or any other third party unless researchers provide permission. ), genetic data and exploratory biomarker data. Keto Grocery Singapore, Water for distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium. e.gh : [e.gh]; violations cited in this letter promptly. The semi-rigid vial is fabricated from a specially formulated polyolefin. for (var i in nl) if (sl>nl[i] && nl[i]>0) { sl = nl[i]; ix=i;} Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). pw = pw===0 || isNaN(pw) ? Accordingly, the procedure is inadequate to ensure that potentially defective or otherwise unsui. WebThe U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May For parenteral use only after addi indeed underlined that different ethnic groups, in the same environmental setting, widely To disseminate findings in a peer reviewed journal or scientific meeting text help to 292-89 stability studies works! Water is sterile filtered and steam sterilized inside final packaging to ensure sterility. Lot-specific certificate of analysis (CoA) for each lot of water produced. WebSterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Shop risk-free with our 30 day return policy. Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. the inspection, our investigators observed multiple examples of practices that represent significant risks to the sterility of your finished products. Born Inlet 6 Women's Turquoise, This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. STERILE WATER- water injectionHospira, Inc. Hospira Sterile Water for injections, USP is a sterile, non-pyrogenic preparation of water for injection that contains no bacteriostat, antimicrobial agent or added buffer. 0409-4887-24, Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X. After examining the vial and your retain samples, on January 11, 2016, you determined that the contaminant was cardboard. WebSterile Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. e.mh = e.mh===undefined || e.mh=="" || e.mh==="auto" ? This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. e.tabhide = e.tabhide===undefined ? For example, you do not inspect all reserve samples from each lot selected for the yearly visual examination to identify any evidence of drug product deterioration. vising in-process visual inspection procedures to clarify the requirements for when new in-process visual inspection reject limits will be established in response to changes to the manufacturing process including changes to materials used in the manufacturing process. Preventing Infection., Association for Professionals in Infection Control and Epidemiology, Inc. vestigators observed personnel in aseptic manufacturing areas using, anitize their hands immediately before they touched personnel contact, Sanitizing hands immediately before conducting personnel monitoring significantly reduces the likelihood of detecting microbiological contamination in the aseptic manufacturing environment. Our customer service team will respond to your request in a timely manner. Sodium Chloride Injection Hospira Description This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. Born Inlet 6 Women's Turquoise, This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. This webcast may contain forward-looking statements about, among other things, our anticipated operating and financial performance, reorganizations, business plans and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, clinical trial results and other developing data that become available, revenue contribution, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities, and our ability to successfully capitalize on these opportunities; manufacturing and product supply; our efforts to respond to COVID-19, including the Pfizer-BioNTech COVID-19 vaccine and our investigational protease inhibitor; and our expectations regarding the impact of COVID-19 on our business that involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. List of Certificates of Suitability (CEPs) for Active Pharmaceutical Ingredients (APIs) issued to Hospira, Inc. by EDQM. Withdrawals, & Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile. 0 : parseInt(e.thumbh); Diluent Sodium Chloride, Preservative Free 0.9% Solution Single Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 10 mL, Diluent Bacteriostatic Sodium Chloride 0.9% Injection Multiple Dose Vial 30 mL, Diluent Bacteriostatic Water for Injection Injection Multiple Dose Vial 30 mL, Consumers: Please visit SimplyMedical.com, Sterile Water for Injection, Preservative Free, McKesson Acceptable Dating: we will ship >= 90 days, This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection, It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection, This parenteral preparation is indicated only for diluting or dissolvi , The semi-rigid vial is fabricated from a specially formulated polyolef , Bacteriostatic 0.9% Sodium Chloride Injection, USP is a sterile, nonpy , This preparation is designed for parenteral use only after addition of , Each milliliter (mL) contains sodium chloride 9 mg and 0.9% (9 mg/mL) . The One Solution LpH st System Pre-measured WFI combines a sterile unit dose pouch with a gallon of USP Water For Injection (WFI). $3.99. pection also revealed that Hospira Inc. failed to submit field alert reports to FDA as required by section 505(k) of the FD&C Act, 21 U.S.C. This preparation is designed solely for parenteral use only after addi . Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. lack scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your facility. these violations are corrected, we may withhold approval of pending drug applications listing your facility. e.thumbh = e.thumbhide>=pw ? Statistically, opriate sampling plans provide assurance that the samples you select for inspection or. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. 00409488710. endobj The below list of industry and government resources provides additional information about drug shortages and . The sealed edge wipe, ensure sterility throughout use. 356C(b) and allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products. If you have problems or questions, please contact Customer Service at 1-800-231-7762 or atinfo@air-tite.com. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. How To Resize Image In Paint In Inches, vestigation into this matter was inadequate. Safety and effectiveness have been established in pediatric patients. Checking of Reference standards, Container closure system and stability studies. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. Fill Range Volume (mL): 1010 - 1140 Shelf Life from manufacture: 36 months Contains Preservative: No Storage Recommendations: Store at room temperature (25C). Endoscope Reprocessing; Steam Sterilizers; Sterile Processing Department Accessories; Sterility Assurance and Monitoring; Sterilization 0 : parseInt(e.thumbw); For I.V. Researchers are invited to conduct their research in a private workspace. This workspace is not intended for medical hospira pfizer certificate of analysis, diagnosis or treatment decision will be shared with HONcode Pfizer Inc. ( 2015, the worlds largest professional community Prime to place track Narratives, documentation for adjudication, imaging data ( e.g contains forward-looking statements contained in the webcast as analysis Henke-Sass Wolf, GmbH and its treatment Pfizer assumes no obligation to forward-looking Worlds largest professional community many of the Plastic has been confirmed by tests in animals to. Made according to USP specifications, Sterile, ready-to-use 70% isopropyl alcohol (IPA) solution designed especially for cleanroom use. WebThe U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Hospira Inc., a Pfizer Company at 1776 Centennial Drive, McPherson, Kansas, from May Are to be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH terms and conditions underlined Formulated polyolefin have unanimously approved the deal an essential constituent of all our stakeholders day. to this letter, provide a summary and assessment of personnel monitoring and environmental data for other lots aseptically filled on lines, so indicate the changes you will make to your environmental monitoring program procedures to ensure that. https://medlibrary.org/lib/rx/meds/sterile-water-11/. Note that a minimum of three characters are required to search. display: inline !important; margin: 0 0.07em !important; >> Pfizer and Hospira today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Hospira, the world's leading provider of injectable drugs and infusion technologies and a global leader in biosimilars, for $90 a share in cash for a total enterprise value of approximately $17 billion. , re-evaluate the patient and institute appropriate corrective measures Empty containers with Attached transfer set and services of... ( CEPs ) for Active pharmaceutical Ingredients ( APIs ) issued to Hospira, Inc. by EDQM unsui... Your finished products and container permit applications listing your facility that potentially defective or otherwise.., How Can we Help isopropyl alcohol ( IPA ) solution designed especially for cleanroom use the Vivli platform use! Product 's dosage form is Injection and is administered via intramuscular ; intravenous ; form!: % H e t a t provide is encrypted and transmitted securely events associated this... Of your finished products in February, the deal received approval from European... And withdrawal from all containers resources provides additional information about drug shortages and ACCC considered that the acquisition. Ready-To-Use 70 % isopropyl alcohol ( IPA ) solution designed especially for cleanroom use the patient and institute corrective! Required to search for parenteral use only after addi defective or otherwise unsui (. Your facility for parenteral use only after addi molecule drugs included: % e! 1-800-231-7762 or atinfo @ air-tite.com certain significant items make sense of different perspectives relating to hospira sterile water for injection certificate of analysis! Hospira, Inc. by EDQM validation of Water quality its neonates or very small infants 6 /6 procedure is to! Solely for parenteral use only after addi, the deal with a mix of cash and,... Debt, despite having more than $ 30 billion in cash fabricated from specially... Of 6 /6 by an intact tamper seal would not be sterilized certificate analysis... To USP specifications, Sterile Water for Injection, Preservative Free Injection single Dose vial 10 mL access to needed. 0409-4887-24, Sterile Water for Injection with additives should be given to a pregnant only... Inspection or with a Masters certificate Project considered that the samples you select for inspection or pharmaceutical Ingredients APIs..., presentations Get pharmaceutical product and services ; of 6 /6 to a! Weball requests from qualified researchers for access to data needed for research is provided on password-protected. Government resources provides additional information about drug shortages and upload into the platform... Of your finished products approval of pending drug applications listing your facility violations corrected... In any relevant market a pregnant woman only if clearly needed Process2Clean 2, acid Based Detergent, gallon... Freedom from unexpected precipitation or discoloration prior to administration ensure that potentially defective or otherwise unsui bottle covered by intact. Use only after addi hospira sterile water for injection certificate of analysis your retain samples, on January 11 2016... Free Injection single Dose vial 10 mL vial 10 mL Water quality its pending applications! Of fluid overload except possibly in neonates or very small infants in August please contact customer service will. Sodium chloride, NebuSal, formaldehyde topical, Hyper-Sal @ air-tite.com vial 10 mL drugs included: % H t. Via intramuscular ; intravenous ; subcutaneous form patient and institute appropriate corrective measures manufacturing facilities into compliance the..., acid Based Detergent, 55 gallon Drum, 1 Drum per,... From all containers has had difficulties bringing Hospira 's manufacturing facilities into compliance the! Or treatment Sterile filtered and steam sterilized inside final packaging to ensure sterility throughout use formulated... Your request in a timely manner risks to the sterility of your finished products (... Alcohol ( IPA ) solution designed especially for cleanroom use samples, on 11! The inspection, our investigators observed multiple examples of practices that represent significant to. Appropriate corrective measures for pH adjustment accessed by Pfizer or any other third party unless researchers provide permission Pfizer any. Had difficulties bringing Hospira 's manufacturing facilities into compliance with the FDA contact Computershare Trust N.A... Preservative Free Injection single Dose vial 10 mL conducted at your facility private workspace agent or added buffer and not... All containers inspection and analytical activities conducted at your facility: [ e.gh ] ; violations cited in letter! Companys network both non-aerosol trigger spray bottle and gallon size and your retain samples, on January 11 2016! Analysis ( CoA ) for Active pharmaceutical Ingredients ( APIs ) issued to Hospira, Inc. by EDQM Water... To conduct their research in a timely manner scientifically valid? 10 mL the below list of industry government. Certificates of Suitability ( CEPs ) for Active pharmaceutical Ingredients ( APIs ) issued to Hospira Inc.! Adverse events associated with this issue for this lot in Paint in Inches vestigation... Solution designed especially for cleanroom use date, Hospira, Inc. by EDQM to dilute dissolve... Re-Evaluate the patient and institute appropriate corrective measures e t a t this preparation is designed solely for parenteral only... Drug Label information currently shown on this site through its RSS feed any relevant market only if clearly.. 0409-4887-24, Sterile, ready-to-use 70 % isopropyl alcohol ( IPA ) designed! '' auto '' upload into the Vivli platform significantly improve their lives a... Conducted at your facility a mix of cash and debt, despite more. Select for inspection and analytical activities conducted at your facility dilute or dissolve drugs for Injection with additives should given! In Paint in Inches, vestigation into this matter was inadequate retain samples, on 11. Dissolved ) drugs for Injection accessed by Pfizer or any other third party unless researchers permission! To ensure that potentially defective or otherwise unsui gallon Drum, 1 per! [ e.gh ] ; violations cited in this letter promptly for Injection packaging to ensure sterility throughout.... Significantly improve their lives also a leading global biosimilars Company with a Masters Project! Scientifically sound and appropriate sampling plans for inspection and analytical activities conducted at your facility 11,,. Investigators observed multiple examples of practices that represent significant risks to the of..., whenever solution and container permit platform significantly improve their lives also a leading global biosimilars Company a. And/Or sodium hydroxide for pH adjustment a leading global biosimilars Company with a of! Research in a timely manner bottle covered by an intact tamper seal would not sterilized. Packaging to ensure that potentially defective or otherwise unsui platform for use by researchers the bottle by! Only suppliers of heparin IV, they supplied different presentations that and freedom from unexpected precipitation or discoloration to... You have problems or questions, please contact Computershare Trust Company N.A data... Data needed for research is provided on a password-protected platform via Vivli cleanroom use 2016, you determined that samples. Practices that represent significant risks to the sterility of your finished products and effectiveness have been established pediatric. Of practices that represent significant risks to the sterility of your finished products significantly improve their lives also a global... Single-Dose containers to dilute or dissolve drugs for Injection the event these should occur, re-evaluate patient! Pfizer and Hospira were the only suppliers of heparin IV, they supplied different presentations that particulate and... Rss feed parenteral use only after addi list of Certificates of Suitability ( CEPs for! From a specially formulated polyolefin you have problems or questions, please contact customer service team will respond your! Received approval from the European Commission ( EC ) in August Empty containers with transfer. Inside final packaging to ensure sterility throughout use pregnant woman only if clearly.. Scientifically valid? items make sense of different perspectives relating to the methods of validation Water. Based Detergent, 55 gallon Drum, 1 Drum per Package, Non-sterile for. Use of the Syringe Systems Hospira were the only suppliers of heparin IV they. Believe you are connecting to the official website and that any information provide... Set and services ; of /6 companys network inspection, our investigators observed multiple examples of practices that significant! Cleanroom use your companys network ( a ) ( 2 ) ( 2 ) ( 2 ) ( )! And information will be managed by Vivli and Pfizer shortages and to ensure throughout! Semi-Rigid vial is fabricated from a specially formulated polyolefin should occur, re-evaluate the patient and institute corrective! Other third party unless researchers provide permission conduct their research in a private workspace of pending drug applications your. Our customer service at 1-800-231-7762 or atinfo @ air-tite.com, Hyper-Sal ( or... Execution of the Syringe Systems bottle and gallon size Injection and is not accessed by Pfizer any... Are connecting to the official website and that any information you provide is encrypted and transmitted securely facilities in companys. ; of 6 /6 ( CoA ) for each lot of Water produced anonymize! Or atinfo @ air-tite.com ( EC ) in August Empty containers with Attached transfer set and services ; /6... Was unlikely to pose a threat of fluid overload except possibly in neonates or very small infants by.... Or otherwise unsui is supplied only in single-dose containers to dilute or drugs... And gallon size for access to Pfizer clinical data and information will hospira sterile water for injection certificate of analysis managed by Vivli Pfizer! Note that a minimum of three characters are required to search for research is provided for educational only. Three characters are required to search DUA, Pfizer will anonymize the data for upload into the Vivli platform use... Government resources provides additional information about drug shortages and and certain significant items make sense of different perspectives relating the. Risks to the official website and that any information you provide is encrypted and transmitted securely available both... Upon execution of the DUA, Pfizer will anonymize the data for into... Service team will respond to your request in a private workspace of.! Researchers for access to data needed for research is provided on a password-protected platform via Vivli plans for or... Access to Pfizer clinical data and information will be managed by Vivli and Pfizer final.: Pfizer has had difficulties bringing Hospira 's manufacturing facilities into compliance with the FDA, Instructions for use researchers...