FDA 483 - YI WU JC IMPORT & EXPORT CO LTD

An FDA inspection of Biotechnologinės farmacijos centras Biotechpharma UAB, a drug substance manufacturer in Vilnius, Lithuania, revealed significant deficiencies across multiple areas. Observations included inadequately designed equipment leading to contamination risks, insufficient preventive maintenance procedures, and an inadequate disinfectant efficacy study. Additionally, the firm's environmental monitoring program was found to be deficient.