# Pfizer Inc. – FDA 483, May 8, 2009

Source: https://www.keypedia.com/records/483/pfizer-inc/a46c9db1-8b85-4598-a0ce-dcca3b22933e

> FDA 483 for Pfizer Inc. on May 08, 2009. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Inc.
- Inspection Date: 2009-05-08
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Groton Laboratories, Pfizer Inc. in Groton, CT, received a Form FDA 483 following an inspection of its non-clinical laboratory. The inspection revealed issues related to the accurate recording and verification of experimental data, including dose formulation details and storage documentation. Additionally, the final study reports failed to accurately specify the storage locations for all specimens.

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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