483
Tianjin Asymchem Pharmaceuticals Co., Ltd.FDA 483 - Tianjin Asymchem Pharmaceuticals Co., Ltd. - March 29, 2024
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Record Details
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.
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ID · 70ec7c08-b1e3-48d5-8835-1912d7e16e61