FDA 483 - PolyPeptide Laboratories, Inc. - May 10, 2024

PolyPeptide Laboratories Inc. in Torrance, CA, an API manufacturer, was cited for significant deficiencies in its cleaning validation processes. The firm's Cleaning Process Performance Qualifications Protocols and Reports (CPPQ) were found to be insufficient, lacking scientific justification, containing questionable data reporting, and failing to adequately justify established dirty hold times. These issues indicate a lack of robust control over equipment cleaning practices for commercial and non-commercial API batches.