483
Pfizer Inc.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.
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ID · 8ee3fdca-bb25-4c24-a736-b48d75f0f082