FDA 483 - AN Co. Ltd. - May 30, 2017

AN Co. Ltd. in Yeongdong-gun, Korea, was inspected and found to have significant deficiencies across laboratory controls, production, and material systems. The inspection revealed issues including inadequate product specifications leading to recalls, lack of investigations for batch failures, insufficient stability testing, incomplete laboratory records, and unvalidated manufacturing processes. These observations indicate a systemic failure to adhere to good manufacturing practices, posing potential risks to drug product quality and patient safety.