FDA EIR - Pfizer Inc. - July 14, 2010

An FDA inspection was conducted at Pfizer Laboratories Division of Pfizer Inc. in Groton, CT, from July 13 to July 14, 2010. The inspection focused on the Scientific and Laboratory Services (SLS) operations, covering quality and laboratory systems for both human and veterinary drug products. Specific areas reviewed included stability testing services, oversight of the reference standards program, surveillance testing for contract manufacturers, and analytical sciences. The regulatory framework for the inspection involved assessing the firm's adherence to current Good Manufacturing Practices (cGMPs) and its own written procedures for drug products subject to approved New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs). The scope included a detailed review of laboratory operations, equipment qualification, calibration programs, and data management systems, including their 21 CFR Part 11 compliance. Crucially, the inspection concluded with a positive outcome. The FDA investigator found that Pfizer appeared to be operating in conformance with its written procedures and cGMPs. No significant violations or issues were identified. Consequently, an FDA-483, which lists inspectional observations, was not issued, and no recommendations were made to management. This indicates that no specific corrective or required actions were mandated by the FDA following this inspection.