# FDA 483 - Pfizer Manufacturing Deutschland GmbH - February 03, 2020

Source: https://www.globalkeysolutions.net/records/483/pfizer-manufacturing-deutschland-gmbh/eebbafa1-775a-45e8-b8f9-bf8533e358d8

> FDA 483 for Pfizer Manufacturing Deutschland GmbH on February 03, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Manufacturing Deutschland GmbH
- Inspection Date: 2020-02-03
- Product Type: drugs
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: An FDA inspection of Pfizer Manufacturing Deutschland GmbH in Freiburg im Breisgau, Germany, revealed significant deficiencies in the firm's quality control unit, written procedures for production and process controls, and discrepancy investigations. The observations highlight a lack of adequate oversight and control over critical manufacturing processes and product quality. These issues indicate a need for comprehensive improvements in the firm's quality management system for drug product manufacturing.

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## Related Officers

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- [Shanshan Wu](https://www.globalkeysolutions.net/people/shanshan-wu/09c04470-15ef-4342-85d7-af0abe5a49fe)
- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.globalkeysolutions.net/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)

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

Office: https://www.globalkeysolutions.net/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe