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FDA Regulatory Compliance for the Pharmaceutical, Biotechnology and Medical Device Arenas

SMITHKLINE BEECHAM, LTD, CORK IRELAND RECEIVES WARNING LETTER FROM FDA (03/18/14)

April 3, 2014 By Barry Friedman Leave a Comment

FIRM FAILS TO SUFFICIENTLY INVESTIGATE PHARMACEUTICAL WASTE CONTAMINATION EVENT During an FDA investigation of SKB in Cork, Ireland, the FDA encountered an unusual situation where the pharmaceutical waste tank was found to have contaminated various other tankage used to manufacture APIs. Part of the rationale provided by SKB was that no reason existed … [Read more...]

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