FDA 483 - Kingchem Laboratories Inc.

Apiscent Labs, LLC, an API and Food Flavoring Manufacturer in St. Francis, WI, was cited for significant deficiencies across its quality system. The inspection revealed failures in quality control unit responsibilities, incomplete investigations into out-of-specification results and deviations, and inadequate procedures for raw material handling, supplier verification, and stability chamber management. These observations indicate a lack of robust controls to ensure product quality and compliance.