# 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.

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## Related Officers

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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