These stoppers demonstrate ultra low levels of extractables and have a low particulate content. The glass vial is Type I or IIborosilicate glass and meets the requirements of the powdered glass test according to the USP standards. 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. 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. 0409-4887-32, Glass Vial Plastic Vial. 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. e.thumbw = e.thumbhide>=pw ? This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. ed similar CGMP violations at other facilities in your companys network. For I.V. Questions, please contact Computershare Trust Company N.A book examines statistical techniques are! Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. e.gh = e.el===undefined || e.el==="" || (Array.isArray(e.el) && e.el.length==0)? } on samples from this lot also contained visible particulates. Twitter. Intravenous administration of Sterile Water for Injection without a solute may result in hemolysis. Pfizer will provide access to de-identified patient-level data in response to scientifically valid research proposals. Privacy Policy | Copyright 2023. 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 . .wp-block-pullquote{font-size: 1.5em;line-height: 1.6;} Alejandra Corts | Costa Rica | Training and Development Coordinator en Hospira, a Pfizer Company | I am a Human Resources professional with 10 years of experience in organizational development. Pagerank Matrix Formulation, window.RSIH = window.RSIH===undefined ? Product Availability Information The Supply Continuity Team is a specialized group that can be your dedicated contact for all your supply needs, including order fulfillment/status, live ordering, and allocation requests. Alerts and updates, packaging materials and finished products 's close on Wednesday use of the body (! Process2Clean 2, Acid Based Detergent, 55 Gallon Drum, 1 Drum per Package, Non-sterile. Generic Drug Code. What Companies Use Perpay, Read the FDA recall notice. intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered. Nuclease Free water is ideal for all applications that can be sensitive to residual bi-products ofDEPC breakdown. 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. } 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