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

Cosway Company, Inc., an OTC Drug Manufacturer, received an FDA Form 483 following an inspection from February 27 to March 10, 2017. The inspection revealed significant deviations from current Good Manufacturing Practices (cGMP). Key violations included a failure to thoroughly investigate out-of-specification (OOS) results, lacking proper batch disposition, corrective actions for identified errors, and validation for reworked batches. Customer complaint records were also deficient, frequently missing complete investigation findings and follow-up actions. These were repeat observations from previous inspections, indicating persistent non-compliance.

Further issues encompassed improper storage conditions for drug products due to a lack of temperature mapping and monitoring, alongside unmaintained and uncalibrated equipment. Laboratory controls were insufficient, with inadequate data integrity measures for computerized systems, undocumented test preparations, and poor management of chemical reagent inventory, including the use of expired materials. The firm also lacked a comprehensive change control system for facilities, equipment, and laboratory procedures. Its stability testing program was deficient in tracking samples and investigating OOS stability results. Additionally, raw material supplier evaluation procedures were inadequate, and employee training records for key personnel were incomplete.

To address these observations, Cosway Company, Inc. is required to implement robust corrective and preventive actions across its quality systems, including investigation processes, documentation, equipment maintenance, laboratory controls, change management, stability programs, supplier qualification, and employee training, to achieve compliance with cGMP regulations.