Thai Nakorn Patana Co., Ltd, – FDA 483, Aug 4, 2023

Thai Nakorn Patana Co., Ltd, a drug manufacturer in Mueang Nonthaburi, Thailand, was cited for significant deficiencies across its quality control laboratory, production processes, equipment management, and employee training. The inspection revealed failures in drug product testing, inadequate laboratory records for standards and calculations, undocumented deviations, and lack of proper equipment qualification and cleaning procedures. These issues indicate a systemic lack of adherence to Good Manufacturing Practices, potentially impacting the quality and safety of drug products distributed to the US market.