CHUNGDO PHARM. CO. LTD. – FDA Warning Letter, Mar 7, 2013

An FDA inspection of ChungDo Pharm. Co. LTD. in South Korea from March 4-7, 2013, revealed significant violations of the Quality System (QS) regulation (21 CFR Part 820) for its Chemview-10 and Chemview-11 urinalysis test strips, rendering them adulterated devices. The firm's response to the FDA 483 was not reviewed due to late submission. Key deficiencies include the failure to establish and maintain adequate procedures for corrective and preventive actions (CAPA) (21 CFR 820.100(a)(b)), device design validation, particularly stability studies (21 CFR 820.30(g)), control of nonconforming product (21 CFR 820.90(a)), disposition authority for nonconforming product (21 CFR 820.90(b)(1)), and receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)). These issues indicate serious problems in the firm's manufacturing and quality management systems. ChungDo Pharm. Co. LTD. is required to provide a written response within fifteen business days detailing corrective actions, preventive measures, and a timeline for completion. Failure to correct these violations will impact premarket approval applications for Class III devices and the issuance of Certificates to Foreign Governments, and may be considered by U.S. federal agencies for contract awards.