# FDA 483 - Pfizer Inc. - December 13, 2024

Source: https://www.keypedia.com/records/483/pfizer-inc/0a8f268c-7a50-424d-b28d-4f771fa8db04

> FDA 483 for Pfizer Inc. on December 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Inc.
- Inspection Date: 2024-12-13
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Pfizer Inc.'s nonclinical laboratory in Groton, CT, revealed two significant observations. The firm failed to conduct nonclinical laboratory studies in accordance with the established protocol, specifically regarding dose administration and animal termination dates. Additionally, the study director did not ensure that all raw data and documentation, including email correspondence, were properly transferred to the archives at the close of a study.

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## Related Officers

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Company: https://www.keypedia.com/companies/pfizer-inc/f8b3c75f-1ec4-46eb-97f9-f66bedfe6fe7

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144