FDA WARNING_LETTER - Foshan Jinxiong Technology Co., Ltd. - August 18, 2017

The FDA issued a Warning Letter to Foshan Jinxiong Technology Co., Ltd., a contract manufacturer of over-the-counter (OTC) drug products for children in China, following an inspection from August 15-18, 2017. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering the firm's drug products adulterated under the FD&C Act. The firm's September 3, 2017, response was deemed inadequate. Key violations included: failure to perform appropriate laboratory determination of satisfactory conformance to final specifications for each drug product batch, including active ingredient identity and strength, prior to release (21 CFR 211.165(a)); failure to conduct identity testing for each component and to establish the reliability of component supplier analyses (21 CFR 211.84(d)(1) and (2)); failure to establish and follow an adequate written stability testing program (21 CFR 211.166(a)); and failure to prepare complete batch production and control records (21 CFR 211.188). The FDA emphasized that contract manufacturers are responsible for drug quality and strongly recommended engaging a qualified CGMP consultant. As a result, the firm was placed on Import Alert on February 14, 2018. Failure to correct these violations may lead to continued refusal of admission of products into the U.S. and withholding of new drug application approvals. The firm must respond within 15 working days with corrective actions and a timeline.