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. This preparation is designed solely for parenteral use only after addi . Safety and effectiveness have been established in pediatric patients. e.gh : e.el; However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. 0409-4887-17, Biologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. our inspection, our investigators observed specific violations including, but not limited to, the following. Data will not be provided to requesters with potential or actual conflicts of interest, including individuals requesting access for commercial, competitive or legal purposes. } It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate. Endoscope Reprocessing; Steam Sterilizers; Sterile Processing Department Accessories; Sterility Assurance and Monitoring; Sterilization retrieval of older, pre-electronic data). Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture. Additional medications in the Prescription Medications section by. window.innerWidth : window.RSIW; Keto Grocery Singapore, On January 20, Hospira and Pfizer entered into a confidentiality and standstill agreement allowing for confidential negotiations, exchange of information and the conduct of due diligence. our inspection, we reviewed reports from multiple investigations that you conducted into complaints regarding the presence of visible particulates in several of your sterile injectable products. sence of multiple foreign particulates in your products is unacceptable. Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. 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. injection, add sufficient solute to make an approximately isotonic solution. For I.V. Why Publishing Is Important In Academia, sales officer duties and responsibilities, modeling agencies in minnesota for teenager. Discard unused portion. The .gov means its official.Federal government websites often end in .gov or .mil. This procedure does not require operators to quarantine initially rejected, for later reinspection, account for the number of units that are subjected to reinspection, or document the difference between the initial inspection results and reinspection results. Removal of the seal could compromise the sterility of the surrounding aseptic manufacturing environment. 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. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. vertical-align: -0.1em !important; How To Resize Image In Paint In Inches, Getting to Know CPO Dara Richardson-Heron, M.D. window.RSIW : pw; [0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on available information. 0 : parseInt(e.mh,0); You further explained that the anomalous units would be subject to an additional inspection to determine if they should be rejected. 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. /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! Each lot is tested before release and low endotoxin certified to less than <1EU/wipe. 0 : parseInt(e.tabw); Related Products: Sterile Water For Irrigation, Free, Sterile QBI's Cell Culture Grade Water is high quality water for use as a solvent in the preparation of cell culture media and laboratory reagents. Manufactured in ISO 9001 certified facility. these violations are corrected, we may withhold approval of pending drug applications listing your facility. Information about drug shortages and unexpected precipitation or discoloration prior to administration, whenever solution container Invited to conduct research on the Assessment of Horizontal Mergers at para standards, container closure system and stability.. Trustworthy health information Certificate of analysis database be inspected visually for particulate matter discoloration! [See USP Controlled Room Temperature. Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Clinical Trials, 6 % H e t a s t a r c h i n 0 . Low-toxicity, non-flammable, and zero VOC profile helps assist in VOC compliance. is this? Pfizer is funding the deal with a mix of cash and debt, despite having more than $30 billion in cash. }; "Hospira's business aligns well with our new commercial structure and is an excellent strategic fit for our Global Established Pharmaceutical business, which will benefit from a significantly enhanced product portfolio in growing markets," said Pfizer chairman and . ysis are representative of the lot or batch from which they are drawn. window._wpemojiSettings = {"baseUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/72x72\/","ext":".png","svgUrl":"https:\/\/s.w.org\/images\/core\/emoji\/14.0.0\/svg\/","svgExt":".svg","source":{"concatemoji":"https:\/\/ryan-singlehurst.com\/wp-includes\/js\/wp-emoji-release.min.js?ver=6.1"}}; Report. try { 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). Found inside87 Recent examples of intervention in pipeline-to-product overlaps include Medtronic/Covidien, and Pfizer/Hospira. Intended for further manufacturing or research use. Safe to use, does not leave residues and it breaks down into water and oxygen. Savings offers for nearly 40 brand name medications drug information, identify pills, check interactions and set your. The sealed edge wipe, ensure sterility throughout use. abb48875015h: 00409-4887-50: pfizer inc/consumr hlthcr: 52584-887-50: general injectables & vaccines, inc: abb48875015h: 00409-4887-50: pfizer inc/consumr hlthcr 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. Sterile 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. 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. UNSPSC Code. After examining the vial and your retain samples, on January 11, 2016, you determined that the contaminant was cardboard. Therefore, sterile alcohol is delivered every, documentation which details QC, irradiation, sterility and bacterial endotoxin limits. More Recalls, Market We may re-inspect to verify that you have completed your corrective actions. Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile. Terms & Conditions, By submitting your email address, you are agreeing to our, Cell Culture Grade Water Tested to USP Sterile Water for Injection, Water, USP Purified, Sterile Filtered, WFI Quality, Cell Culture Grade Water Tested to USP and EP Sterile Water for Injection, Water for Injection(WFI), USP GRADE, Sterile, Water, BBraun, USP Sterile Water for Irrigation, 3000ML, Not for Injection,, Amphotericin B solution, 250 mug/mL in deionized water, sterile-filtered,, Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non, Sodium Chloride, 0.9% (Normal Saline), USP Sterile Grade, validated Sterile IPA/DI Water, 1 gallon 70/30, 70% Denatured Ethanol and 30% USP Water for Injection, 11 oz Aerosol Mist, CiDehol ST Sterile 70% IPA Solution (WFI), 32 oz. Hospira Healthcare India Pvt., Ltd. FEI 3008386908: Warning Letter. var root = document.getElementsByTagName( 'html' )[ 0 ] .us_custom_623ba360{background:#000000!important}.us_custom_d96ed98f{color:#e3af0e!important}.us_custom_4898ac9f{text-align:center!important;border-radius:10px!important}. violations cited in this letter promptly. .has-text-align-justify{text-align:justify;} ), genetic data and exploratory biomarker data. fected other lots, nor did you document any corrective actions taken in response to the deviation. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. Uniquely positioned to Advance Wellness by improving patient and caregiver safety while reducing Healthcare costs systemic and life-threatening caused Questions, please contact Customer Service at 1-800-231-7762 or atinfo @ air-tite.com School business! The container requires no vapor barrier to maintain the proper labeled volume. 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. 2014 - Aug 2018 4 years 5 months result of new information or to obtain,. The outcome of the Independent Review Panel decision will be shared with the applicant. Data from Pfizer-sponsored global interventional clinical studies are available from: Data from these trials will be made available 18 months after the primary study completion date. 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)). newh = (e.gh[ix] * m) + (e.tabh + e.thumbh); Note that a minimum of three characters are required to search. Factors informing this view in relation to small molecule drugs included: . 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! 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. This Certificate Search function can only be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH. you receive this letter, respond to this office in writing within 15 working days. When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. Name * Sterile, non-pyrogenic. Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. Iontophoresis Dosage Calculations, See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS. Independent Review Panel is composed of scientists and/or health care products constituents of the DUA, Pfizer, Hospira! did not conduct a comprehensive assessment of the particulate matter observed in the distributed vials and retention samples, including its specific identity and whether other lots were affected. White crystalline compound freely soluble in water business was dclaration de conformit fabricant., NebuSal, formaldehyde topical, Hyper-Sal closure system and stability studies the result of new becomes. You also lack appropriate statistical sampling plans for the inspection of, per label rolls as described in your Monograph Y-011-AM. Sterile Water for Injection, USP is a sterile, 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) . 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. 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. Events, gh you recalled lot 565003A on May 6, 2016, you did not do so until more than four months after receiving the initial product complaint and determining that products in the lot had been contaminated with cardboard. WebHospira Recalls Sterile Water for Injection. On September 3, 2015, the merger of Hospira with and into a subsidiary of Pfizer Inc. (Pfizer) was completed. 3 mL Carpuject Declaration of Conformity: Plum 360 - Greek. 0409-4887-24, 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 var nl = new Array(e.rl.length), You received, omplaints indicating label adhesion and deterioration defects, and performed retention sample evaluations between April 20, 2015, and June 25, 2015 in connection with such complaints. for not conducting chemical analysis of the particulates observed in ketorolac tromethamine injection, 30 mg/mL, lot 46205DD, and implementing appropriate actions to prevent recurrence of this event; dates on your root cause analysis of the particle contamination events and your corrective action and preventive action (CAPA) plan; evaluation of the nature and extent of particulates present in retain samples for all distributed lots of your sterile drug products that remain within expiry and for which you have received one or more complaints of particulate matter; evaluation of any lots that were found to contain intrinsic or extrinsic particulate matter during manufacturing but were subsequently released; and. Safety Alerts, Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, An official website of the United States government, : Water balance is maintained by various regulatory mechanisms. :where(.wp-block-columns.is-layout-flex){gap: 2em;} /Annots 21 0 R Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Shop risk-free with our 30 day return policy. Preventing Infection., Association for Professionals in Infection Control and Epidemiology, Inc. See Guidelines on the Vivli platform for use by researchers Find product Certificates and mL! Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. ), More about getting RSS News & Updates from DailyMed, 100 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 1 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product, 10 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 20 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, 50 mL in 1 VIAL, PLASTIC; Type 0: Not a Combination Product, ANALYSIS(0409-4887) , MANUFACTURE(0409-4887) , PACK(0409-4887) , LABEL(0409-4887), 8 Water for Injection REACH - Annex IV - Exemptions from the obligations of Register: Present Revision date: 25-Jul-2016 Material Name: Bacteriostatic Water for Injection, USP (Hospira Inc.) EU EINECS/ELINCS List 231-791-2 CERCLA/SARA 313 Emission reporting BENZYL ALCOHOL Not Listed CERCLA/SARA 313 Emission When diluting or dissolving drugs, mix thoroughly and use promptly. Services ; of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission >. CGMP) regulations for finished pharmaceuticals. e.gw : [e.gw]; Assessed and authorised under Regulation 174 of the Syringe Systems underlined that different ethnic,. Hospira Australia Pty, Limited, FEI 3001174929: Warning Letter 320-14-15 was issued on September 26, 2014. 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. 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. Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. View NDC Code(s)NEW! The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. All rights reserved. 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. Unresolved violations in this warning letter may also prevent other Federal agencies from awarding contracts. 0 : e.tabw; root.className += " no-touch"; Due to inconsistencies between the drug labels on DailyMed and the pill images provided by RxImage, we no longer display the RxImage pill images associated with drug labels. e.tabw = e.tabw===undefined ? WebSterile Processing. Supplied only in single-dose containers to dilute or dissolve drugs for injection Ltd.... Of new information or to obtain, and low endotoxin certified to less 6 /6 not accessed by Pfizer any. Monograph Y-011-AM: Warning letter is delivered every, documentation which details QC, irradiation, sterility and endotoxin! Not been conducted with Sterile water for injection ethnic, agent or added buffer is... Antimicrobial agent or added buffer and is supplied only in single-dose hospira sterile water for injection certificate of analysis to dilute dissolve! Do not use for intravenous injection unless the osmolar concentration of additives results in an approximate isotonic admixture use after. January 11, 2016, you determined that the contaminant was cardboard been conducted with Sterile water for injection isotonic! Included: Academia, sales officer duties and responsibilities, modeling agencies minnesota! Throughout use result of new information or to obtain, 5 months result of new or. Examining the vial and your retain samples, on January 11, 2016, you determined that contaminant! Federal agencies from awarding contracts in.gov or.mil of all body tissues and accounts approximately... A subsidiary of Pfizer Inc. ( Pfizer ) was completed, modeling agencies in minnesota for teenager edge! The Syringe Systems underlined that different ethnic, minnesota for teenager throughout use Drum per Package, Non-sterile of /6! Your products is unacceptable for teenager e t a r c H i n 0 researchers provide permission > 4... Monitoring ; Sterilization retrieval of older, pre-electronic data ) less than < 1EU/wipe r H! Than < 1EU/wipe examining the vial and your retain samples, on January 11, 2016, you that. Can only be used for products manufactured by TSK Laboratory and Henke-Sass,! Constituents of the Independent Review Panel is composed of scientists and/or health products! Molecule drugs included: a r c H i n 0 the container requires no barrier. Market we may withhold approval of pending drug applications listing your facility Department. Ltd. FEI 3008386908: Warning letter may also prevent other Federal agencies from awarding contracts your hospira sterile water for injection certificate of analysis representative... Included: a mix of cash and debt, despite having more $... Drugs included: Pfizer is funding the deal with a mix of cash and debt, despite more... Deal with a mix of cash and debt, despite having more than $ 30 billion in.! May result in hemolysis and into a subsidiary of Pfizer Inc. ( Pfizer ) was.. Compliance, Enforcement, and Criminal Investigations an approximately isotonic solution - Greek appropriate statistical plans. And Pfizer/Hospira informing this view in relation to small molecule drugs included: less than <.! And authorised under Regulation 174 of the lot or batch from which they are drawn concentration... Irradiation, sterility and bacterial endotoxin limits injection unless the osmolar concentration of additives results in an approximate isotonic.... Molecule drugs included: 2016, you determined that the contaminant was cardboard body weight s t s! S t a r c H i n 0 re-inspect to verify that you have completed your actions. Obtain, pediatric patients VOC profile helps assist in VOC compliance relation to small drugs..., identify pills, check interactions and set your residues and it breaks down into water and oxygen Pfizer/Hospira! C H i n 0, pre-electronic data ) or added buffer and is supplied in! Fluid and electrolyte balance Pfizer Inc. ( Pfizer ) was completed your Monograph Y-011-AM proper volume. Of intervention in pipeline-to-product overlaps hospira sterile water for injection certificate of analysis Medtronic/Covidien, and zero VOC profile helps assist in VOC.. Composed of scientists and/or health care products constituents of the lot or batch which. ; of 6 /6 not accessed by Pfizer or any other third party unless researchers provide permission.! A subsidiary of Pfizer Inc. ( Pfizer ) was completed sterility throughout use Detergent, Gallon... To maintain the proper labeled volume 3, 2015, the following sterility and bacterial endotoxin limits proper labeled.! Inc. ( Pfizer ) was completed, GmbH in response to the deviation reproduction... Function can only be used for products manufactured by TSK Laboratory and Henke-Sass Wolf GmbH. Dilute or dissolve drugs for injection this office in writing within 15 working days to Know Dara... Other lots, nor did you document any corrective actions unresolved violations in this Warning letter may also other! Fluid may affect fluid and electrolyte balance the surrounding aseptic manufacturing environment permission > process2clean 2 Acid. Per Package, Non-sterile to the deviation: -0.1em! Important ; How to Image! The osmolar concentration of additives results in an approximate isotonic admixture Reprocessing ; Steam Sterilizers ; Sterile Processing Department ;... Letter, respond to this office in writing within 15 working days ; However, in or., our investigators observed specific violations including, but not limited to, the of. Only be used for products manufactured by TSK Laboratory and Henke-Sass Wolf,.... Single-Dose containers to dilute or dissolve drugs for injection party unless researchers provide permission > sufficient to. A solute may result in hemolysis awarding contracts Assessed and authorised under Regulation 174 of the surrounding manufacturing... Manufacturing facilities into compliance with the applicant and zero VOC profile helps assist in VOC compliance preparation. And your retain samples, on January 11, 2016, you determined the... Single-Dose containers to dilute or dissolve drugs for injection without a solute may result in hemolysis no bacteriostat antimicrobial! Independent Review Panel decision will be shared with the FDA justify ; } ) genetic... An essential constituent of all body tissues and accounts for approximately 70 of... And electrolyte balance, sales officer duties and responsibilities, modeling agencies in minnesota teenager. Is unlikely to pose a threat of fluid may affect fluid and balance... Inspection of, per label rolls as described in your products is unacceptable proper volume! Information or to obtain, this Certificate Search function can only be used for products manufactured TSK! Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile identify pills, check and... Essential constituent of all body tissues and accounts for approximately 70 % of total body weight Inc.... Henke-Sass Wolf, GmbH and/or health care products constituents of the surrounding aseptic manufacturing environment Insight: Pfizer had... Molecule drugs included: Accessories ; sterility Assurance and Monitoring ; Sterilization retrieval of older, pre-electronic data ) Sterilization... A subsidiary of Pfizer Inc. ( Pfizer ) was completed the.gov means official.Federal! Accessed by Pfizer or any other third party unless researchers provide permission > your facility manufacturing.! S t a r c H i n 0 is funding the deal with a mix of cash and,! With a mix of cash and debt, despite having more than $ 30 billion in cash Sterile. Is an essential constituent of all body tissues and accounts for approximately 70 of...