FDA EIR - Pfizer Inc. - January 08, 2021

An FDA surveillance inspection of Pfizer Inc. Groton Laboratories was conducted from January 4 to January 8, 2021, focusing on Good Laboratory Practice (GLP) for nonclinical studies under regulatory framework CP 7348.808 and CFR Part 58. The inspection covered various aspects including the physical plant, personnel, quality assurance, equipment, and a specific study (20GR142) supporting an Emergency Use Authorization. A positive finding was that previous inspection observations from 2017 regarding hematology histograms and calibration records were adequately addressed through updated Standard Operating Procedures (SOPs). Crucially, no Form FDA-483 (Inspectional Observations) was issued during this inspection, indicating no significant violations. However, the inspector discussed several areas for improvement with management. These included ensuring a balance used for test article preparations was clearly marked if not user-ready, clarifying the status of two 2017 non-GLP studies on the Master Schedule, properly indexing transfer documents for sold studies within the archive, and enhancing future protocols to detail procedures for redrawing clotted blood samples, especially for small test systems. Management agreed to consider these suggestions.