FDA 483 - Tianjin Asymchem Pharmaceuticals Co., Ltd. - October 19, 2021

An FDA inspection conducted at Tianjin Asychem Pharmaceuticals Co., Ltd., an API manufacturer in TEDA West Tianjin, P.R. China, from October 13 to October 19, 2021, resulted in a Form FDA 483 observation. The primary finding concerned the company's inadequate procedures for qualifying its suppliers, specifically for a registered starting material designated (b) (4) Code (b) (4) Batch No.(b) (4).

The inspection revealed that the firm qualified this supplier, identified as a trader, based solely on a review of documents. This 'desk audit' approach led to the acceptance of materials accompanied by the trader's Certificate of Analysis, without a thorough evaluation of the supplier's manufacturing practices, testing methodologies, or release testing protocols. This process did not ensure compliance with the essential principles of Good Manufacturing Practices (GMP) for pharmaceutical raw material sourcing. To address this regulatory deficiency, Tianjin Asychem Pharmaceuticals Co., Ltd. is expected to implement comprehensive corrective actions. These actions should aim to enhance their supplier qualification program, ensuring robust assessments of their suppliers' quality systems to prevent future recurrences and uphold product quality and patient safety standards.