FDA WARNING_LETTER - Wuhan Chinese Moxibustion Technology Dev. Co., Ltd. - May 26, 2017

The FDA inspected Wuhan Chinese Moxibustion Technology Dev. Co., Ltd. from May 22-26, 2017, identifying significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, the firm's drug product is deemed adulterated under section 501(a)(2)(B) of the FD&C Act. The firm's initial response was inadequate. Key deficiencies include the failure to establish an adequate quality control unit with proper authority and written procedures (21 CFR 211.22(a) and (d)), and the failure to prepare master production and control records (21 CFR 211.186(b)). The firm also failed to establish adequate laboratory controls, lacking scientifically sound specifications and quantitative testing for active pharmaceutical ingredients (21 CFR 211.160(b)). Furthermore, there was a failure to establish adequate written procedures for production and process control, including process validation (21 CFR 211.100(a)), and to properly clean and maintain equipment, with observations of rusted equipment and chipped paint (21 CFR 211.67(a)). Beyond CGMP, product labeling issues were noted: the active ingredient strength was below the Tentative Final Monograph (TFM) proposed range, and some inactive ingredients were not recognized by FDA. The FDA strongly recommended engaging a CGMP consultant. As a result of these violations, the firm was placed on Import Alert 66-40, and FDA may refuse admission of products and withhold approval of new applications until full compliance is achieved. A written response detailing corrective actions is required within 15 working days.