FDA 483 - PolyPeptide Laboratories San Diego LLC - May 15, 2025

PolyPeptide Laboratories San Diego LLC, an API manufacturer, was cited for failing to follow written procedures for cleaning equipment. Specifically, unclean and corroded fume hoods were observed in both manufacturing and quality control labs, with no documentation of weekly cleaning. This indicates a significant lapse in maintaining equipment sanitation and adherence to established protocols.