FDA warns GSK on manufacturing practices at Canada plant

Tue Jun 24, 2014 10:16am EDT
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June 24 (Reuters) - The U.S. Food and Drug Administration said an unit of GlaxoSmithKline Plc violated quality requirements during the manufacture of influenza vaccine Flulaval.

In a warning letter, the FDA said the company had failed to take appropriate steps to prevent microbiological contamination of drugs, among other violations.

The FDA also said that controls for the purified water system at the Quebec City plant were inadequate to prevent contamination. (1.usa.gov/1jL3UUS) (Reporting by Esha Dey in Bangalore; Editing by Sriraj Kalluvila)