Merck Serono Biotech API, Injectable and Testing Sites in Europe Draw FDA Warning Letter

An FDA warning letter to Darmstadt, Germany-headquartered Merck KGaA reflects GMP problems found during an FDA inspection tour that extended across three Merck Serono European sites involved with biotech products – an API facility, a pre-filled syringe filling plant and a testing lab.

The December warning letter, made available by FDA in mid-February, resulted from contiguous inspections at the three sites located in Fenil-sur-Corsier, Switzerland (biotech API), Aubonne, Switzerland (syringe filling), and Rome, Italy (testing), conducted in June and July, 2011.

FDA’s first stop was at Merck Serono’s API site.  Of concern at the site was the addition of an API to a suite using previously “dedicated equipment” without reporting the change as required.

The approved finished product application included a commitment to manufacture the API at the Swiss facility using dedicated equipment for all surfaces that come into direct contact with the API solution.  However, subsequent to the approval, the API was added in the suite, and no change was reported.

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