# FDA 483 - Pfizer Inc. - September 22, 2017

Source: https://www.keypedia.com/records/483/pfizer-inc/8ee3fdca-bb25-4c24-a736-b48d75f0f082

> FDA 483 for Pfizer Inc. on September 22, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pfizer Inc.
- Inspection Date: 2017-09-22
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Pfizer Inc. Groton Laboratories, a GLP Testing Facility in Groton, CT, received a Form 483 with two observations. The inspection revealed issues with the retention of raw data from nonclinical laboratory studies and inadequate record-keeping for equipment maintenance and quality control data. These findings indicate deficiencies in data integrity and documentation practices.

## Related Documents

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- [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

- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

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