FDA EIR - KPC Products Inc - December 20, 2017

An FDA inspection of KPC Products Inc., a manufacturer and distributor of herbal dietary supplements in Irvine, CA, was conducted from December 14-20, 2017. The inspection, part of the HAFW5 FY18 work-plan and conducted under Compliance Program 7321.008 for Dietary Supplements, focused on the firm's adherence to Good Manufacturing Practices (GMPs).

The inspection revealed 11 significant observations, many of which were repeat violations from a previous 2014 inspection. Key issues identified included a widespread failure to establish and follow written procedures and specifications for critical aspects of dietary supplement manufacturing. Specifically, the firm lacked identity specifications for components, did not conduct identity testing for dietary ingredients, and failed to establish specifications for the purity, strength, and composition of both components and finished dietary supplements. Furthermore, KPC Products Inc. did not adequately verify that finished batches met product specifications, nor did they establish in-process specifications. Deficiencies were also noted in quality control operations, master manufacturing records, and batch production records, which lacked complete information. The firm also failed to maintain records of material review and disposition for returned dietary supplements.

Management, including the Operations Supervisor, was informed of the observations and indicated they would provide a written response to the Agency within 15 business days. Discussions also highlighted the need for KPC Products Inc. to retain representative samples for all components, a point previously raised.