FDA WARNING_LETTER - Okamoto Rubber Products Co., Ltd. - November 07, 2019

On February 14, 2020, the FDA issued a Warning Letter to a firm in Klongluang, Pathumthani, Thailand, following an inspection from November 4-7, 2019. The firm manufactures lubricated natural rubber condoms, which are classified as devices. The inspection revealed these devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System regulation (21 CFR Part 820).

Key violations include: 1. **Failure to adequately validate processes (21 CFR 820.75(a)):** The firm did not validate the rework process for the treatment of natural latex condoms using the same coating material. The firm's response was inadequate, as it did not commit to a retrospective review of other potentially unvalidated manufacturing processes or provide supporting documentation. 2. **Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)):** Documentation for Corrective Action Request (CAR) No. NC17/004 lacked adequate support for investigation and identification of corrective actions. Additionally, an updated Corrective Action Procedure, required from a previous FDA inspection, was only approved in English, not the native Thai language used for the quality system, for over two years. The firm