FDA 483 - Synthetopes Inc - May 16, 2019

Synthetopes Inc, a producer of sterile drugs in Conway, SC, was cited for significant deficiencies in its manufacturing processes during an FDA inspection. The firm failed to conduct essential sterility and potency testing for its radiological and nuclear injectable drug products, lacked validation for aseptic processes and sterilization, and exhibited poor environmental monitoring and equipment sanitation. These issues indicate a severe lack of control over microbiological contamination and product quality, raising concerns about the safety and efficacy of its sterile drug products.