# 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.

---

## 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.

## Related Documents

- [483 - 2017-09-22](https://www.keypedia.com/records/483/pfizer-inc/8ee3fdca-bb25-4c24-a736-b48d75f0f082)
- [EIR - 2018-06-21](https://www.keypedia.com/records/eir/pfizer-inc/b154586d-d538-42b1-a8ae-1deb0881329c)
- [EIR - 2021-01-08](https://www.keypedia.com/records/eir/pfizer-inc/629953a9-16fe-44af-88db-4dd1a6fe19f3)
- [EIR - 2017-01-12](https://www.keypedia.com/records/eir/pfizer-inc/4dff771c-0dab-46fc-abe5-407affe333a8)
- [EIR - 2017-06-28](https://www.keypedia.com/records/eir/pfizer-inc/52dfe47f-362a-44e3-adb8-479f50ec1e77)

## 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