China Resources Sanjiu Medical and Pharmaceutical Co., Ltd. – FDA Warning Letter, Mar 28, 2014

The FDA issued a Warning Letter to China Resources Sanjiu Medical and Pharmaceutical Co., Ltd. following a March 2014 inspection in Shenzhen, China, identifying significant CGMP violations (21 CFR Parts 210 and 211) that render drug products adulterated (Section 501(a)(2)(B)). CGMP deficiencies included inadequate laboratory testing for active ingredient identity/strength (21 CFR 211.165(a)), insufficient specifications and test procedures (21 CFR 211.160(b)), and an inadequate stability testing program (21 CFR 211.166(a)). Equipment surfaces were also found to be reactive or absorptive (21 CFR 211.65(a)). Additionally, the firm failed to register its current manufacturing facility and fulfill drug listing obligations (Section 510(i)(1), (i)(2), (j)). Several OTC drug products were cited as unapproved new drugs and misbranded. 999 Ganmaoling Cold Capsule and Packets were unapproved (Section 201(p)) due to non-monograph dosages and misbranded (Section 502(f)(2)) for lacking required warnings (21 CFR Part 341). 999 Itch Relief Ointment was also an unapproved new drug (Section 201(p)) as it's not covered by any OTC monograph. The firm's response was insufficient, and products have already been refused admission to the U.S. A written response detailing corrective actions and prevention measures, with supporting documentation, is required within fifteen working days. Failure to comply may lead to further regulatory actions, including withholding new drug application approvals.