FDA WARNING_LETTER - Hunan Norchem Pharmaceutical Co. Ltd. - July 28, 2017

The FDA inspected Hunan Norchem Pharmaceutical Co. Ltd. in Jinshi, Hunan, China, from July 24-28, 2017, and identified significant deviations from current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (API). As a result, the firm's API are considered adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. The FDA found the firm's August 18, 2017, response, which claimed discontinuation of (b)(4) base manufacturing for the U.S. market and transfer of operations, to be inadequate in demonstrating compliance. Key violations included the failure to prepare and use complete production and control records for API batches, with numerous batch records for (b)(4) base being untraceable, and the approval of batch records with inaccurate raw material weights. Additionally, the firm failed to maintain complete analytical raw data for laboratory tests, citing data deletion after an instrument transfer. These deficiencies highlight a lack of understanding of basic compliant manufacturing operations, including adequate documentation, trained personnel, and written procedures. Consequently, the firm was placed on Import Alert 66-40 on October 18, 2017. The FDA may withhold approval of new applications and continue to refuse admission of articles manufactured by the firm into the U.S. The company must investigate these deviations, determine their causes, and implement corrective actions, providing a written response within 15 working days.