FDA 483 - Teh Seng Pharmaceutical Mfg. Co., Ltd. 3rd Plant - August 04, 2023

An FDA inspection of Teh Seng Pharmaceutical Mfg. Co., Ltd. in Tainan City, Taiwan, revealed two significant observations related to quality control. The firm failed to ensure laboratory controls included scientifically sound standards, specifically regarding the qualification of working standards against primary reference standards. Additionally, investigations into unexplained discrepancies were found to be inadequate, with CAPAs lacking proper documentation for root causes, impact evaluations, and effectiveness processes.