FDA 483 - Cosway Company, Inc. - October 27, 2023

Cosway Company, Inc. in Carson, CA, a contract manufacturer of OTC drug products, was cited for significant deficiencies during an FDA inspection. Observations included a lack of appropriate controls over computer systems, specifically an unvalidated Excel spreadsheet used for stability data without an audit trail or proper security. Additionally, the firm failed to thoroughly investigate out-of-specification temperature and humidity readings for stability chambers used in OTC drug product stability studies.