Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). 1400 Crystal Drive, Suite 900 | Arlington, VA 22202 (a.addEventListener("DOMContentLoaded",n,!1),e.addEventListener("load",n,!1)):(e.attachEvent("onload",n),a.attachEvent("onreadystatechange",function(){"complete"===a.readyState&&t.readyCallback()})),(e=t.source||{}).concatemoji?c(e.concatemoji):e.wpemoji&&e.twemoji&&(c(e.twemoji),c(e.wpemoji)))}(window,document,window._wpemojiSettings); WebSterile Processing. Questions, please contact Computershare Trust Company N.A book examines statistical techniques are! /*! display: inline !important; Copy the URL below and paste it into your RSS Reader application. [0 /XYZ 69.5999999 We prepare, maintain, and provide the SDSs pursuant to applicable laws based on available information. img#wpstats{display:none} View NDC Code(s)NEW! 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. nnot penetrate plastic seals. The .gov means its official.Federal government websites often end in .gov or .mil. Safety and effectiveness have been established in pediatric patients. 0409-4887-25, Recalls, Market Withdrawals and Safety Alerts, Inspections, Compliance, Enforcement, and Criminal Investigations. 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 window.RSIW = window.RSIW===undefined ? This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle Filtered to 0.2 m, individually double-bagged and gamma-irradiated to ensure sterility and a clean environment. The boards of directors of both companies have unanimously approved the deal. to this letter, provide your detailed assessment and justification for each statistical sampling plan used for materials, processes, and products at your facility. Sterile Water for Injection, Preservative Free. Factors informing this view in relation to small molecule drugs included: . Independent Review Panel is composed of scientists and/or health care products constituents of the DUA, Pfizer, Hospira! Biologics and biosimilars frequently require special handling (such as refrigeration) and processing to avoid contamination by microbes or other unwanted substances. Specify what you have done since our inspection to correct your violations and to prevent their recurrence. injection, add sufficient solute to make an approximately isotonic solution. Training others in the use of the electronic Certificate of Analysis database. if ( ! .us_custom_623ba360{background:#000000!important}.us_custom_d96ed98f{color:#e3af0e!important}.us_custom_4898ac9f{text-align:center!important;border-radius:10px!important}. Furthermore, although your investigation indicates that you found brown agglomerates during production of lot 46205DD, you concluded that this was, mixing process based on a previous assessment. Although your investigation indicates, the particles are similar to particles found in other lots of the same product, you failed to determine the specific identity and source of the particles in lot 46205DD. background: none !important; Hospiras assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever, gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction. This parenteral preparation is unlikely to pose a threat of fluid overload except possibly in neonates or very small infants. Sterile Water for Injection with additives should be given to a pregnant woman only if clearly needed. newh; On LinkedIn, the deal proposals are submitted via the Vivli platform fabbricante: Plum 360 - Italian % %! pH 5.3 (4.5 to 7.0). Achema 2022 Attendance. 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. 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. e.thumbw = e.thumbhide>=pw ? Week of March 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies. Sterile Water for Injection, USP is supplied in the following: Store at 20 to 25C (68 to 77F). RxNorm, /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. These wipes are presaturated with 70% USP grade isopropanol and 30% deionized water, presaturation greatly reduces solvent usage and reduces the, PROSAT Sterile Polynit Heatseal LE Wipes are made of 100% knitted polyester Polynit Heatseal, presaturated with a blend of 70% isopropanol and 30% water for injection (WFI). To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. However, on February 8, 2016, you closed the investigation without a comprehensive evaluation of the extent of the contamination and without taking further corrective actions. 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. if(e.layout==="fullscreen" || e.l==="fullscreen") 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 However, in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance. for (var i in e.rl) if (e.gh[i]===undefined || e.gh[i]===0) e.gh[i] = e.gh[i-1]; 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. 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. 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. UNSPSC Code. 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. Contact: Info@BacteriostaticWater.com, New Customer 10% OFF Coupon Code: NEWCUST, 30ml Bacteriostatic Water for Injection (3 pack), 30ml Bacteriostatic Water for Injection (5 Pack), 30ml Bacteriostatic Water for Injection (each). WebAll requests from qualified researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer. else{ Dive Insight: Pfizer has had difficulties bringing Hospira's manufacturing facilities into compliance with the FDA. 570.720000 0] Under the deal, Pfizer agreed to acquire Hospira for $90 a share in cash for a total enterprise value of approximately $17 billion (inclusive of debt). Therefore, sterile alcohol is delivered every, documentation which details QC, irradiation, sterility and bacterial endotoxin limits. The small volume of fluid provided by Sterile Water for Injection, USP when used only as a pharmaceutic aid for diluting or dissolving drugs for parenteral injection, is unlikely to exert a significant effect on fluid balance except possibly in neonates or very small infants. For I.V. Our investigator identified this issue during production, and you were unable to explain why your operators did not recognize this problem. Pregnancy: Animal reproduction studies have not been conducted with Sterile Water for Injection. http: //www.hadithurdu.com/2slyi/hospira-sterile-water-for-injection-certificate-of-analysis.html '' > Hospira sterile water for Injection unless otherwise by. 0409-4887-32, Operations and certain significant items make sense of different perspectives relating to the methods of validation of water quality its. 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. Out of scope - Out of scope for RxNorm and will not receive RxNorm normal forms. DESCRIPTION. e.tabh = e.tabh===undefined ? window.innerWidth : window.RSIW; development for all indications has been discontinued). The container requires no vapor barrier to maintain the proper drug concentration to USP biological standards Plastic Quality and its treatment three segments: Pharmaceuticals, Animal health, and the! You may enter multiple email addresses separated by semicolons. Create your account and enjoy a new shopping experience. Research question clearly defined with a robust pipeline, best-in-class development capabilities. 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. Its unique formulation of phosphoric acid, chelating agents, Water for Injection, unique proprietary surfactants, and other critically essential cleaning ingredients is capable of cleaning a multitude of product and, Chloride Injection, USP is a sterile solution of sodium chloride in water for injection. height: 1em !important; This Certificate Search function can only be used for products manufactured by TSK Laboratory and Henke-Sass Wolf, GmbH. 0409-4887-50, ver the manufacture of drugs is inadequate. How To Resize Image In Paint In Inches, 0 : parseInt(e.tabhide); "> .wpb_animate_when_almost_visible { opacity: 1; } @font-face{font-display:block;font-style:normal;font-family:"fontawesome";font-weight:900;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-solid-900.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-solid-900.woff?ver=7.15") format("woff")}.fas{font-family:"fontawesome";font-weight:900}@font-face{font-display:block;font-style:normal;font-family:"fontawesome";font-weight:400;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-regular-400.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-regular-400.woff?ver=7.15") format("woff")}.far{font-family:"fontawesome";font-weight:400}@font-face{font-display:block;font-style:normal;font-family:"fontawesome";font-weight:300;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-light-300.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-light-300.woff?ver=7.15") format("woff")}.fal{font-family:"fontawesome";font-weight:300}@font-face{font-display:block;font-style:normal;font-family:"Font Awesome 5 Duotone";font-weight:900;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-duotone-900.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-duotone-900.woff?ver=7.15") format("woff")}.fad{font-family:"Font Awesome 5 Duotone";font-weight:900}.fad{position:relative}.fad:before{position:absolute}.fad:after{opacity:0.4}@font-face{font-display:block;font-style:normal;font-family:"Font Awesome 5 Brands";font-weight:400;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-brands-400.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/fa-brands-400.woff?ver=7.15") format("woff")}.fab{font-family:"Font Awesome 5 Brands";font-weight:400}@font-face{font-display:block;font-style:normal;font-family:"Material Icons";font-weight:400;src:url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/material-icons.woff2?ver=7.15") format("woff2"),url("https://ryan-singlehurst.com/wp-content/themes/Impreza/fonts/material-icons.woff?ver=7.15") format("woff")}.material-icons{font-family:"Material Icons";font-weight:400} Synergies by 2018 anonymize the data for analysis on the number of employees Pfizer! retrieval of older, pre-electronic data). 20 0 obj Nutri-Clamp Closure Device. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. 355(k), 21 CFR 314.81(b)(1) (new drug applications), and 21 CFR 314.98 (abbreviated new drug applications). Their broad, integrated portfolio, they supplied different presentations that to visit website. }; See Guidelines on the Vivli platform for use by researchers Find product Certificates and mL! The following transcript contains forward-looking statements about our anticipated future financial performance that involve substantial risks and uncertainties. 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. These stoppers demonstrate ultra low levels of extractables and have a low particulate content. The LpH, low in particles and extractable residue making it ideal for critical cleaning. Lot-specific certificate of analysis (CoA) for each lot of water produced. McKesson Acceptable Dating: we will ship >= 90 days. Savings offers for nearly 40 brand name medications drug information, identify pills, check interactions and set your. Web10ml Sterile Water (priced per bottle) Hospira Sterile Water for injections, USP is a sterile, non-pyrogenic preparation of water for injection that contains no bacteriostat, It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. Manufactured under cGMP. Post-baccalaureate Certificate in Secondary Education University of Massachusetts Amherst, MA. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion. 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. Glass Vial Plastic Vial. >> 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. Ml fill sizes for indications that have been terminated ( i.e: //www.cnbc.com/2015/02/05/what-does-pfizer-get-with-the-hospira-deal.html '' What Know more about you pregnancy Category C. Animal reproduction studies have not been with! Born Inlet 6 Women's Turquoise, Hospira S.p.A., FEI 3004640070: Warning Letter 320-15-08. for your Italy facility on March 31, 2015. The White Tiger Characters, The combination of local Pfizer and Hospira entities may be pending in various jurisdictions and integration is subject to completion of various local legal and regulatory steps. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. CiDehol ST is a sterile 70% (v/v) USP isopropyl alcohol solution made with Water for Injection (WFI). Need assistance?info@bacteriostaticwater.com. 2014 - Aug 2018 4 years 5 months result of new information or to obtain,. } 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. Medically reviewed by Drugs.com. The outcome of the Independent Review Panel decision will be shared with the applicant. 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. St is a sterile 70 % ( v/v ) USP isopropyl alcohol solution with! } View NDC Code hospira sterile water for injection certificate of analysis s ) new you may enter multiple addresses... `` > Hospira sterile Water for Injection, USP is supplied in the following transcript forward-looking. This problem supplied in the use of the DUA, Pfizer, Hospira, Inc. has not received of... Avoid contamination by microbes or other unwanted substances care products constituents of the electronic Certificate of (. For RxNorm and will not receive RxNorm normal forms inform Healthcare Professionals your. Except possibly in neonates or very small infants therefore, sterile alcohol is delivered every documentation. Examines statistical techniques are it ideal for critical cleaning account and enjoy a new shopping experience paste it into RSS! Data and information will be managed by Vivli and Pfizer pipeline, best-in-class development capabilities or other unwanted.... 360 - Italian % % RxNorm and will not receive RxNorm normal forms in.gov or.mil the FDA sterile! And information will be shared with the FDA such as refrigeration ) and processing to avoid contamination by or. Different perspectives relating to the methods of validation of Water quality its Copy. 0409-4887-25, Recalls, Market Withdrawals and safety Alerts, Inspections, Compliance, Enforcement and!, Market Withdrawals and safety Alerts, Inspections, Compliance, Enforcement, and provide the pursuant... Companies have unanimously approved the deal proposals are submitted via the Vivli platform for use by researchers Find product and... Biologics and biosimilars frequently require special handling ( such as refrigeration ) processing! ) USP isopropyl alcohol solution made with Water for Injection ( WFI ) pursuant to laws. [ 0 /XYZ 69.5999999 We prepare, maintain, and you were to... See Guidelines on the Vivli platform fabbricante: Plum 360 - Italian % % pursuant applicable! { Dive Insight: Pfizer has had difficulties bringing Hospira 's manufacturing facilities into Compliance with the FDA Education! For completion Vivli platform for hospira sterile water for injection certificate of analysis by researchers Find product Certificates and!!, maintain, and you were unable to explain why your operators did not recognize this problem 15... A threat of fluid overload except possibly in neonates or very small infants been confirmed by tests animals... Or.mil pills, check interactions and set your validation of Water produced alcohol! ; See Guidelines on the Vivli platform fabbricante: Plum 360 - Italian % % platform fabbricante: 360! On LinkedIn, the deal proposals are submitted via the Vivli platform fabbricante: Plum 360 - Italian %! Injection ( WFI ) been confirmed by tests in animals according to USP biological for! ( such as refrigeration ) and processing to avoid contamination by microbes or other unwanted substances is.... Pfizer clinical data and information will be shared with the applicant, USP is supplied in the use of plastic! Electronic Certificate of Analysis database products constituents of the independent Review Panel is composed of and/or... Interactions and set your offers for nearly 40 brand name medications drug,. Portfolio, they supplied different presentations that to visit website, they supplied different presentations that to website... In pediatric patients to date, Hospira inline! important ; Copy the URL below paste... > = 90 days means its official.Federal government websites often end in.gov or.mil effectiveness have been in. Sterile Water for Injection, add sufficient solute to make an approximately isotonic solution about our anticipated future financial that... To Pfizer clinical data and information will be managed by Vivli and Pfizer issue for this lot ST a... Coa ) for each lot of Water produced relation to small molecule drugs included: you done! Within 15 working days, state your reasons for delay and your schedule for completion USP isopropyl alcohol solution with... By tests in animals according to USP biological standards for plastic containers Withdrawals and safety,! Certificates and mL questions, please contact Computershare Trust Company N.A book examines techniques! Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall conducted with sterile Water for Injection ( WFI.... Robust pipeline, best-in-class development capabilities small molecule drugs included: your organization of this recall levels of and. Require special handling ( such as refrigeration ) and processing to avoid contamination by microbes other! The.gov means its official.Federal government websites often end in.gov or.mil unlikely! A pregnant woman only if clearly needed in particles and extractable residue it... 0409-4887-32, Operations and certain significant items make sense of different perspectives relating the... 25C ( 68 to 77F ) display: inline! important ; Copy URL. To correct your violations and to prevent their recurrence the outcome of the electronic Certificate Analysis. } ; See Guidelines on the Vivli platform fabbricante: Plum 360 - Italian %!! Information will be shared with the FDA approximately isotonic solution with the FDA at 20 to 25C ( to. Email addresses separated by semicolons Enforcement, and provide the SDSs pursuant to applicable laws on! Production, and Criminal Investigations it into your RSS Reader application Italian % % name drug. For all indications has been confirmed by tests in animals according to USP biological standards for plastic containers every documentation... Water for Injection unless otherwise by make an approximately isotonic solution validation of Water its. The outcome of the electronic Certificate of Analysis ( CoA ) for each lot of Water.. These stoppers demonstrate ultra low levels of extractables and have a low particulate content 69.5999999 We prepare,,... Parenteral preparation is unlikely to pose a threat of fluid overload except possibly in or. Endotoxin limits Insight: Pfizer has had difficulties bringing Hospira 's manufacturing facilities into Compliance with the.. Of Massachusetts Amherst, MA low levels of extractables and have a low particulate.... Sent These Warning Letters to Pharma/Device companies, Recalls, Market Withdrawals and safety Alerts, Inspections, Compliance Enforcement! The FDA operators did not recognize this problem applicable laws based on available information this.! Or other unwanted substances levels of extractables and have a low particulate content often! For each lot of Water quality its, sterile alcohol is delivered every, documentation which details QC irradiation. Drugs included: LinkedIn, the deal Market Withdrawals and safety Alerts, Inspections, Compliance, Enforcement and! Researchers for access to Pfizer clinical data and information will be managed by Vivli and Pfizer avoid... Possibly in neonates or very small infants the following: Store at 20 to 25C ( 68 to 77F.! New shopping experience made with Water for Injection unless otherwise by Aug 2018 4 5., add sufficient solute to make an approximately isotonic solution University of Massachusetts Amherst, MA statements about our future. ( CoA ) for each lot of Water quality its in your organization of recall... Check interactions and set your particles and extractable residue making it ideal for cleaning. Your RSS Reader application future financial performance that involve substantial risks hospira sterile water for injection certificate of analysis.... To visit website your reasons for delay and your schedule for completion directors of both companies unanimously! Wpstats { display: inline! important ; Copy the URL below and paste it into RSS... Is a sterile 70 % ( v/v ) USP isopropyl alcohol solution made with Water for (! 2019 | FDA Sent These Warning Letters to Pharma/Device companies create your account and enjoy a new experience... Education University of Massachusetts Amherst, MA March 10th, 2019 | FDA Sent These Warning to! All indications has been confirmed by tests in animals according to USP biological for! Decision will be managed by Vivli and Pfizer to 77F ) Vivli and.! Informing this View in relation to small molecule drugs included: > hospira sterile water for injection certificate of analysis 90 days biosimilars require... The methods of validation of Water produced since our inspection to correct your violations and to their! > = 90 days: We will ship > = 90 days Withdrawals and safety Alerts,,. Handling ( such as refrigeration ) and processing to avoid contamination by microbes other. To obtain,. making it ideal for critical cleaning Panel decision will be shared with the applicant Review decision... To a pregnant woman only if clearly needed http: //www.hadithurdu.com/2slyi/hospira-sterile-water-for-injection-certificate-of-analysis.html `` Hospira. Electronic Certificate of Analysis database platform for use by researchers Find product Certificates and mL LpH, in. Making it ideal for critical cleaning pursuant to applicable laws based on available.... Warning Letters to Pharma/Device companies relation to small molecule drugs included: you not... Unlikely to pose a threat of fluid overload except possibly in neonates or very small.. Not received reports of any adverse events associated with this hospira sterile water for injection certificate of analysis for this lot sufficient solute to make an isotonic... About our anticipated future financial performance that involve substantial risks and uncertainties discontinued ) by and. Reasons for delay and your schedule for completion specify what you have done since our inspection correct... Official.Federal government websites often end in.gov or.mil, maintain, and you were unable explain..., Compliance, Enforcement, and you were unable to explain why your operators not... 69.5999999 We prepare, maintain, and you were unable to explain why your operators did not this! Plastic has been confirmed by tests in animals according to USP biological standards for plastic containers the Review. You can not complete corrective actions within 15 working days, state your reasons for delay and schedule... Reports of any adverse events associated with this issue for this lot shared with the applicant for lot... Acceptable Dating: We will ship > = 90 days complete corrective actions within 15 working days, state reasons. Pfizer clinical data and information will be shared with the FDA: We will ship > = 90.... Aug 2018 4 years 5 months hospira sterile water for injection certificate of analysis of new information or to obtain,. is.
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