Pfizer Inc.September 22, 2017

FDA 483 - Pfizer Inc. - September 22, 2017

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Record Details

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.

Company: Pfizer Inc.
Inspection Date: September 22, 2017
Product Type: Drugs
Office: Division of Northeast Imports
Person: Kent A. Conforti (issuing_officer)

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ID · 8ee3fdca-bb25-4c24-a736-b48d75f0f082