FDA Shames GSK for Contaminated APIs at Ireland Plant
The U.S. FDA issued a warning letter to GlaxoSmithKline after determining that GSK did not take sufficient action to resolve problems after contaminated APIs were found at the drugmaker's Ireland manufacturing plant.
The contaminated ingredient, paroxetine, is used to make antidepressant drugs Paxil and Seroxat. During an October inspection, an FDA investigator reported that paroxetine was contaminated with material from the Cork plant's pharmaceutical waste tank. According to the FDA, some batches of drugs using the contaminated ingredient were later shipped and GSK failed to notify its customers about the lapse.
The most strongly worded portion of the March 18 FDA warning letter stated, "We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact. In your response to the Form FDA-483, you acknowledged that you should have informed your customers of this incident; however, you did not describe any recent or future communication with your customers regarding the incident to rectify the prior lapse."
GSK has responded by stating its plans to recall certain batches of Paxil from wholesalers.
Read the Reuters press release