# FDA 483 - Rottendorf Pharma Gmbh - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/rottendorf-pharma-gmbh/23a72691-d661-41b4-be4a-22890cfeda8f

> FDA 483 for Rottendorf Pharma Gmbh on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rottendorf Pharma Gmbh
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Rottendorf Pharma Gmbh, a drug product manufacturer in Ennigerloh, Germany, identified deficiencies in their instrument calibration procedures. Specifically, the firm failed to adequately evaluate the linearity and accuracy of a mass balance used for in-process testing of core tablets at critical lower weight ranges. This indicates a potential gap in ensuring the quality and consistency of their drug products.

## Related Officers

- [Patric C. Klotzbuecher](https://www.globalkeysolutions.net/people/patric-c-klotzbuecher/cbb2e6b5-b001-457e-9073-33535f02926e)

Company: https://www.globalkeysolutions.net/companies/rottendorf-pharma-gmbh/e63a13cc-bb19-4b83-9c26-200b73395eb1

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1