GSK Receives FDA Warning Over Manufacturing Violations

Earlier this week, the U.S. Food and Drug Administration issued a warning letter to drug-maker, GlaxoSmithKline, citing several manufacturing violations found during a March 2011 inspection of the company’s drug-manufacturing plant in the United Kingdom. More specifically, federal regulators say the company failed to establish proper procedures that would prevent the microbiological contamination of their products. The FDA’s inspection revealed that the disinfectant used to clean the plant’s manufacturing areas was not strong enough to remove all types of bacteria, which could ultimately lead to the contamination of finished drugs. In its warning letter, the FDA also noted that the drug-maker failed to follow various laboratory-control procedures.

Glaxo’s U.K.-based plant supplies the injectable antibiotic, Timentin, to the United States. The company is working closely with the FDA to ensure it corrects the violations noted in the agency’s warning letter, and also remains confident that all batches of Timentin produced in their U.K.-based plant are safe and efficacious.

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