FDA 483 - Syn-Tech Chemical & Pharm. Co., Ltd. - September 19, 2025

An FDA inspection of Syn-Tech Chem. & Pharm. Co., Ltd., a manufacturer of API products, revealed a critical failure in the storage and maintenance of raw materials. The firm was cited for not storing critical raw materials at appropriate temperatures, with observed warehouse temperatures significantly exceeding the conditions specified on material labels and safety data sheets. This indicates a failure to ensure raw materials meet specifications for use in API manufacturing.