# FDA 483 - Pfizer Manufacturing Austria GmbH - November 17, 2023

Source: https://www.keypedia.com/records/483/pfizer-manufacturing-austria-gmbh/cabdaad2-cc56-480b-9e14-0de56d0226d5

> FDA 483 for Pfizer Manufacturing Austria GmbH on November 17, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Manufacturing Austria GmbH
- Inspection Date: 2023-11-17
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Pfizer Manufacturing Austria GmbH, a vaccine manufacturer in Orth An Der Donau, Austria, was cited for deficiencies in maintaining original hardcopy and alternative data systems during an FDA inspection from November 9-17, 2023. The firm failed to ensure records were exact, complete, and secure, with numerous original files missing from their archiving database and inadequate verification checks. Additionally, data management procedures were found to be deficient, impacting the chain of custody and accuracy of GMP production and laboratory data.

## Related Officers

- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.keypedia.com/companies/pfizer-manufacturing-austria-gmbh/2d79bfcd-8a01-4bff-af88-87b75c9dbf2a

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321