FDA EIR - Mentholatum (China) Pharmaceuticals Co., Ltd. - June 21, 2019

A comprehensive FDA inspection of Mentholatum (China) Pharmaceuticals Co., Ltd., conducted from June 17-21, 2019, focused on the manufacturing of Over-the-Counter (OTC) drug products. The inspection, carried out under established drug manufacturing guidelines (CPGM 7356.002), assessed the company's quality, materials, production, and laboratory control systems to ensure compliance with current Good Manufacturing Practices (cGMP).

The inspection resulted in two significant observations documented on a Form FDA-483. Firstly, the company's laboratory controls were found to lack scientifically robust test procedures necessary to ensure that raw materials and finished drug products consistently meet standards for identity, strength, quality, and purity. Secondly, there was a failure to thoroughly investigate unexplained discrepancies and instances where batches or their components did not conform to specifications, even if products had already been distributed.

While previous inspection findings regarding GMP training, test method accuracy, drug product storage, and stability programs were reviewed and addressed, the current observations highlight persistent issues in quality assurance. The company's General Manager committed to providing a written response to the agency within 15 business days. The inspection was classified as "Voluntary Action Indicated" (VAI), with a recommendation for re-inspection as part of the routine work plan to ensure sustained compliance.