FDA 483 - LEC Custom Products, Inc - September 02, 2022

LEC Custom Products, Inc., an OTC drug manufacturer in Mississauga, Ontario, was cited for significant deficiencies across its quality control, production, and labeling operations. The inspection revealed inadequate master production records, failures in deviation management, and issues with equipment qualification and cleaning. Additionally, the firm lacked proper control over labeling and equipment traceability, indicating systemic weaknesses in maintaining cGMP compliance.