# FDA 483 - Pfizer Inc. - October 27, 2010

Source: https://www.keypedia.com/records/483/pfizer-inc/3760b387-6948-487c-88a8-9e13d4149e1a

> 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: Division of Northeast Imports 
- 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 study director failed to ensure timely archiving of raw data for multiple studies. Additionally, the quality assurance unit failed to adequately review final study reports, leading to discrepancies between reported results and source data.

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## Related Officers

- [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)
- [investigator](https://www.keypedia.com/people/m-patricia-murphy/e955e45d-f8e3-46d3-a712-50dd075ca43c)

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

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94