# FDA 483 - Eurofins Biopharma Product Testing Munich GmbH - July 12, 2019

Source: https://www.globalkeysolutions.net/records/483/eurofins-biopharma-product-testing-munich-gmbh/99c0ec8a-914c-43c9-944a-879640079953

> FDA 483 for Eurofins Biopharma Product Testing Munich GmbH on July 12, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins Biopharma Product Testing Munich GmbH
- Inspection Date: 2019-07-12
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Eurofins Biopharma Product Testing Munich GmbH, a contract testing laboratory, revealed significant deficiencies in laboratory records. The firm failed to maintain complete data for stability testing, with issues noted in audit trail review, and did not adequately verify microbial enumeration data against raw colony counts. These findings indicate concerns regarding data integrity and record-keeping practices.

## Related Officers

- [Compliance Officer - CDER/OC/OMQ](https://www.globalkeysolutions.net/people/anita-narula/fbebf5a2-e25c-4e98-9c22-433d9102380c)

Company: https://www.globalkeysolutions.net/companies/eurofins-biopharma-product-testing-munich-gmbh/e6b00a51-7e13-4203-8500-8f3e177a1a99

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