GSK Fails To Warn Customers Of Contaminated Paroxetine (Seroxat/Paxil)


http://www.pharmamanufacturing.com/industrynews/2014/fda-shames-gsk-contaminated-api/

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.

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