FDA EIR - Nowcos Co., Ltd - September 06, 2019

An FDA For-Cause inspection of Nowcos Co., Ltd, an OTC drug manufacturer located in Sejong-myeon, Sejong-si, Korea, was conducted from September 2-6, 2019. This follow-up inspection aimed to assess the firm's corrective actions after a previous inspection in 2017 resulted in an Official Action Indicated (OAI) classification, an import alert (IA 66-40), and a warning letter due to significant Good Manufacturing Practice (GMP) deficiencies. The inspection revealed that Nowcos Co., Ltd had not adequately implemented corrective actions, with seven repeat observations cited. A 10-item FDA-483 was issued, detailing multiple violations of drug manufacturing regulations under the FD&C Act. Key issues included inadequate computer system controls, unvalidated test methods, deficient equipment cleaning, lack of sufficient stability testing for expiration dates, incomplete batch records, inadequate laboratory facilities, failure to test for objectionable microorganisms, and poor record-keeping for equipment inspections and laboratory controls. The firm also failed to make records readily available. Management acknowledged unpreparedness for the inspection and had previously ignored FDA recommendations to hire a GMP consultant. The firm's attempts to outsource lab testing to U.S. facilities were deemed insufficient due to a lack of proper vendor audits and risk assessments. The FDA recommends that the import alert remain active until the company demonstrates full compliance with GMPs and completes all necessary improvements to its manufacturing and quality control systems.