BROOKS STERISCIENCE LIMITED – FDA 483, Feb 1, 2023

An FDA inspection of BROOKS STERISCIENCE LIMITED, a sterile drug products manufacturer in Vadodara, Gujarat, India, revealed significant deficiencies. The firm failed to establish procedures to prevent microbiological contamination, specifically regarding aseptic process simulations that did not accurately represent actual manufacturing conditions. Additionally, the accuracy and sensitivity of cleaning verification test methods were not established, lacking proper documentation for swab identification, recovery factors, and limits of quantification.