Micronisierungs-Kontor Oberrot GmbHMarch 17, 2016

FDA 483 - Micronisierungs-Kontor Oberrot GmbH - March 17, 2016

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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.

Company: Micronisierungs-Kontor Oberrot GmbH
Inspection Date: March 17, 2016
Product Type: Drugs
Office: International Compliance Team
Person: Unnee Ranjan (Investigator)

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ID · db2be205-c750-49b1-9ef4-ecc8093551b6