Hangzhou SunKing Nonwovens Co., Ltd. – FDA Warning Letter, Aug 9, 2018

The FDA issued a Warning Letter to Hangzhou Sunking Nonwovens Co., Ltd. following an inspection from August 7-9, 2018, which revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211). Consequently, the firm's drug products are deemed adulterated under section 501(a)(2)(B) of the FD&C Act. Key deficiencies included the failure to perform appropriate laboratory testing for finished drug products, including identity and strength of active ingredients, prior to release (21 CFR 211.165(a)). The firm also failed to conduct identity testing for incoming components and validate supplier analyses (21 CFR 211.84(d)(1) and (2)). Furthermore, there was no stability program to support assigned expiration dates (21 CFR 211.137(a)), a lack of written procedures for production and process control (21 CFR 211.100(a)), and an inadequate quality control unit (21 CFR 211.22(a)). The FDA noted concerns about the validity of contract laboratory test results. The firm's response was deemed insufficient. Required actions include providing detailed test methods, stability program plans, risk assessments for untested components and unsupported stability, process validation, and a CAPA plan for the quality unit. The firm was placed on Import Alert 66-40, and failure to correct violations may lead to continued refusal of admission of products into the U.S. and withholding of new drug application approvals. A CGMP consultant is strongly recommended.