GSK Warned Over Manufacturing Issues at U.K. Facility

Drug giant GlaxoSmithKline is violating federal food and drug law at a facility in Worthing, England, the FDA said in a letter posted July 19.

The warning letter to GSK (addressed to SmithKline Beecham Limited), dated June 30, cites the firm for lack of appropriate procedures to prevent cross-contamination of drugs i`n the manufacturing process and failure to adequately investigate contaminants at the Worthing facility.

The types of violations that the agency cites in warning letters are often a good indicator of the FDA’s enforcement priorities. The GSK letter concerns the company’s failure to comply with current good manufacturing practices ...