FDA 483 - Petscript Inc. - September 18, 2025

Petscript Inc. in Paris, TX, a producer of sterile and non-sterile drug products, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight a severe lack of written procedures, inadequate validation of aseptic and sterilization processes, insufficient environmental and personnel monitoring, and a complete absence of routine sterility, endotoxin, and potency testing for drug products. The firm also failed to establish a stability testing program and maintain complete batch records, indicating widespread quality control and manufacturing process failures.