FDA 483 - Zhejiang Meimi Technology Co., Ltd. - May 17, 2024

An FDA inspection of Zhejiang Meimi Technology Co., Ltd. in Yiwu, China, a manufacturer of drug products including gels and sprays, revealed significant deficiencies in their quality control and manufacturing processes. Observations included inadequate identity testing for raw materials, a deficient change control system, lack of traceability for drug product lot numbers, and insufficient laboratory controls. Furthermore, the firm failed to adequately qualify equipment, maintain environmental controls, validate cleaning procedures, and ensure complete laboratory records, raising concerns about the quality and purity of distributed products.