FDA WARNING_LETTER - Thai Nippon Rubber Industry Co., Ltd. - May 14, 2015

An FDA inspection of Thai Nippon Rubber Industry Co., Ltd. in Thailand from May 11-14, 2015, revealed that the firm's manufactured condoms are adulterated under 21 U.S.C. § 351(h) for non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required Medical Device Reporting (MDR) information (21 CFR Part 803). Key QS violations included failure to validate processes (21 CFR 820.75(a)), revalidate processes after changes (21 CFR 820.75(c)), control environmental conditions (21 CFR 820.70(c)), and establish adequate Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)). Additionally, the firm failed to develop and implement written MDR procedures (21 CFR 803.17), with deficiencies in event identification, standardized review, timely transmission, and documentation. The firm's June 4, 2015, response was deemed inadequate for most QS violations, and its adequacy for CAPA and MDR issues could not be determined due to lack of documentation. Consequently, the firm's condoms are subject to refusal of admission into the U.S. (detention without physical examination). The FDA requires a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable for completion, emphasizing the need to address systemic problems. The letter also noted the eMDR Final Rule effective August 14, 2015.