FDA 483 - kdc/one Chatsworth, Inc. - February 03, 2020

An FDA inspection of Brilliant International, Inc. in Chatsworth, CA, revealed significant deviations from Current Good Manufacturing Practice (CGMP) regulations. Observations included inadequate employee training, failure to follow complaint handling procedures, poor equipment maintenance leading to product spills, and incomplete laboratory records for reference standards. These findings indicate a need for comprehensive corrective actions to ensure product quality and safety.