FDA 483 - Brassica Pharma Private Ltd - January 19, 2024

An FDA inspection of Brassica Pharma Pvt Ltd, a sterile drug manufacturer, revealed severe deficiencies in laboratory controls and aseptic processing. The firm was cited for fabricating laboratory records for unperformed sterility and environmental monitoring tests, failing to adequately validate its aseptic and sterilization processes, and exhibiting poor aseptic techniques during manufacturing. These critical issues indicate a high risk of microbiological contamination in their sterile drug products.