483
PolyPeptide Laboratories San Diego LLCPolyPeptide Laboratories San Diego LLC – FDA 483, May 15, 2025
Record Details
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.
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ID · 2c96d156-aac6-429a-9d93-50d0eab8bf4c
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