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ePT--the Electronic Newsletter of Pharmaceutical Technology
Vaccine maker Sanofi Pasteur, Inc. received a US Food and Drug Administration Warning Letter, dated June 30, citing "significant deviations" from current good manufacturing practices in the production of monovalent concentrates used in the company?s ?Fluzone? influenza vaccine.
Vaccine maker Sanofi Pasteur, Inc. (Swiftwater, PA, www.sanofipasteur.com)received a US Food and Drug Administration Warning Letter (http://www.fda.gov/foi/warning_letters/g5899d.html),dated June 30, citing "significant deviations" from current goodmanufacturing practices (CGMPs) in the production of monovalentconcentrates used in the company's "Fluzone" influenza vaccine.
In late March, Sanofi Pasteur reported to FDA that some of themonovalent concentrates had failed sterility testing. The source of thecontamination has not been determined nor thoroughly correctly, whichprompted FDA to issue the warning.
The cited deviations included:
In addition, the warning letter cited deviations in the manufacture ofthe monovalent concentrate used to formulate Fluzone that violateSection 501(a)(2)(B) of the FD&C Act and Section 351(a) of the PHSAct.
According to the letter, the deficiencies "are indicative of yourquality control unit not fulfilling its responsibility to assure theidentity, strength, quality, and purity of your drug product [21 CFR 211.22] . . . Failure topromptly correct these deviations may result in FDA initiatingregulatory action without further notice. Such action may includelicense suspension and/or revocation, seizure, and/or injunction."
The plant can continue to make the vaccine, and according to FDA, thedeficiencies should not affect its availability for the 2006-2007 fluseason.