FDA 483 - USV Private Limited

An FDA inspection of USV Private Limited in Dabhel, Daman, India, revealed critical deficiencies across its sterile drug product manufacturing operations. The firm exhibited poor aseptic practices, inadequate environmental controls, and insufficient validation of aseptic processes, posing a high risk of microbiological contamination. Additionally, the visual inspection program for sterile products was found to be inadequate, and laboratory data integrity issues were identified.