NEW YORK, July 4 (newratings.com) – The US Food & Drug Administration (FDA) Monday announced that it has warned Sanofi Pasteur, the vaccine unit of drug manufacturer Sanofi Aventis SA (SNW.ETR), of contamination problems at the latter’s plant in Pennsylvania.
The warning comes after an FDA inspection of the drug company’s plant following reports that some batches of Sanofi Aventis’ influenza drug failed sterility tests in April this year. The FDA said the source of contamination could not be determined, meaning that it was not certain that the problem had been rectified. According to Bloomberg, the FDA said the contamination affected nearly 5% of the company’s vaccine ingredient production during February to April this year. The regulatory agency added, however, that none of the affected material was used to manufacture the vaccines and no contamination had been detected since April. Sanofi Aventis can continue to manufacture the vaccines.
Sanofi Aventis’ Pennsylvania plant manufactures, as per a government contract, inoculations for avian influenza in case of a widespread outbreak. The FDA and Sanofi Aventis said the sterility issue would not affect the company’s work with the National Institutes of Health to develop and test a bird flu vaccine.
