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

Source: https://www.globalkeysolutions.net/records/483/pfizer-manufacturing-deutschland-gmbh/9c532bb6-5a61-4a3d-8875-72387ba64b86

> 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 Biological Products Operations - Division I
- Summary: An FDA inspection of Pfizer Manufacturing Deutschland GmbH in Freiburg im Breisgau, Germany, revealed significant deficiencies in their quality control unit, process controls, and discrepancy investigations. Observations included a lack of quality unit oversight for critical manufacturing documentation and calibration records, absence of written procedures for assessing process alarms, and failure to thoroughly review unexplained discrepancies such as stability chamber excursions and deviation reports. These issues indicate a need for improved quality system implementation to ensure drug product quality and purity.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/pfizer-manufacturing-deutschland-gmbh/d1a9784c-2940-4829-bcb5-092b1a519902)
- [483 - 2020-02-03](https://www.globalkeysolutions.net/records/483/pfizer-manufacturing-deutschland-gmbh/eebbafa1-775a-45e8-b8f9-bf8533e358d8)

## Related Officers

- [Thomas J. Arista](https://www.globalkeysolutions.net/people/thomas-j-arista/37905892-3285-4f3f-b4b5-f963df1e59d3)
- [Wei-hua Emily Wu](https://www.globalkeysolutions.net/people/wei-hua-emily-wu/d55e99f8-1d74-4c86-a004-ff20e5972031)
- [company_representative](https://www.globalkeysolutions.net/people/stephanie-cape/42bd3a4c-2ab9-4a82-a209-856fae24e56d)
- [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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1