FDA EIR - Syn-Tech Chemical & Pharm. Co., Ltd. - March 15, 2019

An FDA Current Good Manufacturing Practice (CGMP) surveillance inspection of Active Pharmaceutical Ingredient (API) manufacturer Syn-Tech Chemical & Pharm. Co., Ltd. was conducted from January 7 to March 15, 2019. The inspection adhered to regulatory frameworks including CP 7356.002 - API Process Inspections and ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. This comprehensive assessment, covering critical systems like quality, materials, production, and laboratory controls, concluded with no significant deficiencies impacting product quality, and no Form FDA 483 (List of Observations) was issued.

Despite the positive overall classification of "No Action Indicated," three areas for improvement were discussed with the company's management. These included installing a dedicated server for backing up computerized instrument system data, revising the data backup standard operating procedure (SOP) to ensure backup DVDs are stored in a secured location separate from the Quality Control laboratory, and performing a risk assessment to potentially adjust alert-action levels for microorganisms in the water system, along with proposing an appropriate monitoring system. Syn-Tech Chemical & Pharm. Co., Ltd. committed to addressing these points and implementing the necessary corrective actions.