FDA WARNING_LETTER - Tianjin New Bay Bioresearch Co., Ltd. - March 06, 2014

On July 28, 2014, the FDA issued a Warning Letter to Tianjin New Baybioresearch Co. Ltd following an inspection from March 3-6, 2014. The inspection revealed that the firm's QuikScreen Multiple (MDMA & OPI) Drug Cup Test and ForSure Rapid One Step Multiple Abuse Drug Screen Test devices were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. Failure to establish and maintain CAPA procedures, specifically lacking documentation for verification/validation of CAPAs 2012-001 and 2012-003. The firm's response was inadequate, lacking evidence of implementation, a systematic review plan, English translations, and personnel training. 2. Failure to establish and maintain complaint handling procedures, specifically lacking provisions for evaluating adverse event reportability for complaints 2013-001 and 2013-002. The response was inadequate, lacking evidence of systematic review, English translations, and personnel training. 3. Failure to document design output in terms allowing adequate evaluation of conformance to design input requirements, specifically for the QuikScreen Multiple (MDMA & OPI) Drug Cup Test. The response was inadequate