FDA 483 - Cosway Company, Inc. - March 10, 2017

Cosway Company, Inc., an OTC drug manufacturer in Long Beach, CA, was cited for significant deficiencies across its quality system during an FDA inspection. Key issues include inadequate investigations of out-of-specification results, deficient complaint handling, poor temperature control for drug product storage, and a lack of proper equipment maintenance and calibration. Furthermore, the firm demonstrated critical gaps in laboratory data integrity, change control, stability testing, supplier evaluation, and employee training, with several observations being repeats from previous inspections, indicating a systemic failure to address prior non-compliance.