FDA WARNING_LETTER - Wuhu Nuowei Chemistry Co., Ltd - September 06, 2024

The FDA inspected Wuhu Nuowei Chemistry Co., Ltd. from September 2-6, 2024, identifying significant Current Good Manufacturing Practice (CGMP) deviations for active pharmaceutical ingredients (APIs), rendering them adulterated under section 501(a)(2)(B) of the FD&C Act. Additionally, the drug (b)(4) was found adulterated under section 501(b) for failing compendial standards. Key violations include the failure to ensure scientifically sound specifications and test procedures for APIs, specifically (b)(4), where impurity limits exceeded USP standards and required related compound testing was omitted. The quality unit failed to exercise its responsibility to ensure CGMP compliance, notably lacking adequate stability data for API retest dates. Furthermore, the firm failed to establish adequate written procedures for cleaning equipment and its release, with cleaning validation being insufficient. These findings indicate an ineffective quality system and inadequate management oversight. The FDA placed the firm's products on Import Alert 66-40 and may refuse admission of articles. The company committed to ceasing drug production for the U.S. market and deregistered, but must clarify future intentions. A response detailing corrective actions is required within 15 working days, and engaging a qualified consultant is recommended if U.S. market manufacturing resumes.