FDA 483 - Western Chemical Inc. - December 23, 2019

Syndel USA in Ferndale, WA, a drug manufacturer, was cited for significant deficiencies in its quality control unit and laboratory operations during an FDA inspection. Observations included failures to follow recall and corrective action procedures for a sub-potent product, inadequate laboratory controls with unqualified personnel verifying test results, and a lack of documented review for HPLC software audit trails to ensure data integrity. These issues indicate a systemic breakdown in ensuring product quality and data reliability.