FDA Issues Warning Letter to GSK Biologicals - - BioPharm International

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FDA Issues Warning Letter to GSK Biologicals


FDA issued a warning letter to GlaxoSmithKline Biologicals (GSK), North America on June 12, 2014 for deviations from cCGMP requirements found during an inspection from Mar. 31 to Apr. 9, 2014 of its influenza vaccine manufacturing facility in Quebec. GSK is making progress in addressing FDA's concerns and is working to meet supply commitments, the company said in a press release.

Problems observed included failure to assure that appropriate written procedures designed to prevent microbiological contamination of drug products are established and followed, such as validation of all aseptic and sterilization processes. FDA also observed deviations in manufacture of intermediates, including inadequate controls for the purified water system and for manufacturing processes. FDA noted that controls are inadequate to prevent bioburden and endotoxin excursions.

FDA acknowledged the company's commitments of corrective and preventive actions. FDA said that GSK had not provided sufficient detail, however, and the agency requested a meeting with senior management.

Sources: FDA, GSK

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