FDA WARNING_LETTER - Sagami Rubber Industries Co., Ltd. - August 05, 2010

An FDA inspection of Sagami Manufacturers Sdn. Bhd. in Perak, Malaysia, from August 2-5, 2010, revealed that their Trojan Polyurethane Supra Condoms are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 351(h)). The manufacturing methods, facilities, or controls do not conform with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation, 21 CFR Part 820. The firm's response to the FDA 483 was not reviewed due to late submission. Key violations include the failure to adequately validate processes (21 CFR 820.75(a)), failure to establish and maintain adequate procedures for analyzing quality data to identify causes of nonconforming product (21 CFR 820.100(a)(1)), and failure to document corrective and preventive action activities and their results (21 CFR 820.100(b)). Due to these serious violations, the devices are subject to refusal of admission into the U.S. (detention without physical examination). The firm must provide a written response within fifteen working days detailing corrective actions, prevention plans, and a timetable for completion. Failure to correct these issues may also impact federal contracts, premarket approvals for Class III devices, and Certificates to Foreign Governments.