Brassica Pharma Pvt. Ltd. — FDA Warning Letter Findings

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)). Design of Aseptic Processing Lines Your aseptic processing equipment design and cleanroom layout are inadequate. Basic design deficiencies and manually intensive interventions in your operations compromise your ability to…

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Microbiology Laboratory Data Integrity Your firm failed to test every batch for sterility as required by your procedures. For example, sterility samples that should have been under incubation from batches produced just prior to the FDA inspection start, were not present and a review…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Poor Practices in the Aseptic Processing Areas During the inspection of your facility, we observed poor practices and behaviors in ISO 5 and ISO 7 areas during the manufacturing of sterile drug products. These…