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

Source: https://www.keypedia.com/records/483/micronisierungs-kontor-oberrot-gmbh/db2be205-c750-49b1-9ef4-ecc8093551b6

> FDA 483 for Micronisierungs-Kontor Oberrot GmbH on March 17, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micronisierungs-Kontor Oberrot GmbH
- Inspection Date: 2016-03-17
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.keypedia.com/companies/micronisierungs-kontor-oberrot-gmbh/6ec4b93e-8c5c-4698-87ad-142419bd60a9

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321