Pfizer Inc. – FDA 483, Oct 27, 2010

An FDA inspection of Groton Laboratories, Pfizer Inc. in Groton, CT, a non-clinical laboratory, revealed significant issues with data management and quality assurance. The inspection found that study directors failed to ensure timely archiving of raw data and that the quality assurance unit failed to accurately review final study reports against raw data. These findings indicate deficiencies in adherence to good laboratory practices concerning data integrity and record-keeping.