Following inspections of the Sanofi Pasteur facility in Swiftwater, Pennsylvania, the FDA issued a warning letter to the pharmaceutical company. The letter outlined several significant problems at the facility, which the FDA said deviated from good manufacturing practices. Some of the observed deviations include failures regarding controlling aseptic conditions, prevention of cross-contamination, and evaluating equipment to ensure its integrity. The standards for good manufacturing practices include specific federal statutes and regulations related to licensed biological products. According to the FDA’s letter to Sanofi Pasteur, “The deficiencies described in the Form FDA 483 and this letter are indicative of your quality control unit not fulfilling its responsibility to assure the identity, strength, quality, and purity of your drug product.” Sanofi Pasteur manufactures vaccines, including the influenza vaccine, Fluzone.
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