# FDA 483 - Pfizer Manufacturing Deutschland GmbH - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/pfizer-manufacturing-deutschland-gmbh/d1a9784c-2940-4829-bcb5-092b1a519902

> FDA 483 for Pfizer Manufacturing Deutschland GmbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Manufacturing Deutschland GmbH
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Pfizer Manufacturing Deutschland GmbH in Freiburg im Breisgau was inspected and cited for significant deficiencies in its quality system. Observations included inadequate written records for drug complaint investigations and unexplained discrepancies, as well as insufficient written procedures for cleaning and maintenance. These issues indicate a lack of robust control over critical manufacturing processes and documentation.

## Related Documents

- [483 - 2020-02-03](https://www.globalkeysolutions.net/records/483/pfizer-manufacturing-deutschland-gmbh/9c532bb6-5a61-4a3d-8875-72387ba64b86)
- [483 - 2020-02-03](https://www.globalkeysolutions.net/records/483/pfizer-manufacturing-deutschland-gmbh/eebbafa1-775a-45e8-b8f9-bf8533e358d8)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

Company: https://www.globalkeysolutions.net/companies/pfizer-manufacturing-deutschland-gmbh/0847af94-33df-4d46-bba1-0c664ea47d08

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