# Pfizer Inc. – FDA 483, Oct 27, 2010

Source: https://www.keypedia.com/records/483/pfizer-inc/2c7f0e83-c6bb-4cf8-a887-a9817989e85a

> FDA 483 for Pfizer Inc. on October 27, 2010. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Inc.
- Inspection Date: 2010-10-27
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Groton Laboratories, Pfizer Inc. in Groton, CT, a non-clinical laboratory, revealed significant issues with data management and quality assurance. The inspection found that study directors failed to ensure timely archiving of raw data and that the quality assurance unit failed to accurately review final study reports against raw data. These findings indicate deficiencies in adherence to good laboratory practices concerning data integrity and record-keeping.

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## Related Officers

- [investigator](https://www.keypedia.com/people/m-patricia-murphy/e955e45d-f8e3-46d3-a712-50dd075ca43c)
- [Investigator](https://www.keypedia.com/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)
- [Douglas Florentino](https://www.keypedia.com/people/douglas-florentino/97ac0438-05a2-42ee-91cc-80ae4a798d09)

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

Office: https://www.keypedia.com/offices/fda-district-office-stoneham-massachusetts/880e6c44-d8c6-449f-be9e-c459a23205d1