483
Micronisierungs-Kontor Oberrot GmbHMicronisierungs-Kontor Oberrot GmbH – FDA 483, Mar 17, 2016
Record Details
An FDA inspection of Micronisierungs-Kontor Oberrot GmbH in Oberrot, Germany, revealed a significant issue with laboratory controls. The firm failed to document laboratory procedures at the time of performance, specifically for particle size testing of API. This deficiency impacts multiple batches of API released for the US market between 2012 and 2015.
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ID · db2be205-c750-49b1-9ef4-ecc8093551b6
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