# FDA 483 - Pfizer Inc. - September 30, 2014

Source: https://www.keypedia.com/records/483/pfizer-inc/604fcf10-3f8c-4f4c-b790-320e59c6dd2a

> FDA 483 for Pfizer Inc. on September 30, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Inc.
- Inspection Date: 2014-09-30
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Pfizer Inc. Groton Laboratories, a nonclinical laboratory, identified one observation. The observation noted that the study director failed to ensure that a protocol amendment for a toxicity study was approved and followed before the changes had already occurred. This indicates a procedural lapse in adhering to study protocols.

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## Related Officers

- [Matthew C. Watson](https://www.keypedia.com/people/matthew-c-watson/a1594b84-f65a-42f9-a06d-a68a49eb4b28)

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