FDA 483 - Tianjin Asymchem Pharmaceuticals Co., Ltd. - March 29, 2024

Tianjin Keynobels Pharmaceuticals Co., Ltd., a pharmaceutical manufacturer in Tianjin, P.R. China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate personnel training and record-keeping, as well as incomplete batch production and control records. These issues indicate a lack of proper control over manufacturing processes and quality assurance.