FDA EIR - PolyPeptide Laboratories, Inc. - November 19, 2021

The FDA conducted a surveillance cGMP inspection of PolyPeptide Laboratories, Inc. in Torrance, CA, from November 15-19, 2021. This inspection focused on the company's manufacturing of active pharmaceutical ingredients (APIs) for both human and animal drug products, covering Quality, Materials, Packaging and Labeling, and Laboratory Control Systems, with limited review of Facilities, Equipment, and Production Systems. The regulatory framework for this review included CPGM 7356.002F for API Process Inspection and CPGM 7371.001 for Animal Drug Manufacturing Inspections. Notably, this inspection served as a follow-up to a previous FDA inspection conducted in August 2019, which had identified a single observation related to the failure to follow established written procedures. During the November 2021 inspection, the FDA verified that PolyPeptide Laboratories had successfully implemented corrective actions to address this prior issue. Crucially, the current inspection concluded without any new objectionable conditions being noted, and therefore, no Form FDA-483 (Inspectional Observations) was issued to the firm. This indicates the company's operations were found to be in compliance with applicable good manufacturing practices. No samples were collected, and no refusals were encountered.