FDA 483 - PolyPeptide Laboratories, Inc. - August 30, 2019

PolyPeptide Laboratories, Inc. in Torrance, CA, an API manufacturer, was cited for failing to follow established written procedures during an FDA inspection. The firm did not adequately investigate the root cause of a plastic contamination complaint and failed to follow procedures for deviation reports, resulting in overlooked sampling and a lack of corrective actions. These issues indicate significant deficiencies in their quality system.