FDA WARNING_LETTER - Wong Lap Kwong Medicine Company Limited - September 22, 2017

The FDA inspected Wong Lap Kwong Medicine Company Limited's drug manufacturing facility in Hong Kong from September 18-22, 2017, identifying significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211). Consequently, their drug product is deemed adulterated under section 501(a)(2)(B) of the FD&C Act. The firm's October 13, 2017, response was inadequate. Key violations included the failure to establish adequate written procedures for the quality control unit (21 CFR 211.22(d)), ensure component identity (21 CFR 211.84(d)(1) and (2)), establish adequate production and process control procedures, including process validation (21 CFR 211.100(a)), and routinely calibrate equipment (21 CFR 211.68(a)). The FDA recommended engaging a CGMP consultant. Additionally, labeling concerns were raised regarding unlisted inactive ingredients. As a result, the firm was placed on Import Alert 66-40 on January 8, 2018. The FDA may withhold approval of new applications and refuse admission of products until all violations are corrected and compliance is confirmed. The company must respond within 15 working days with a comprehensive corrective action plan, including timelines and impact assessments.