Brassica Pharma Pvt. Ltd. – FDA Warning Letter, Jan 19, 2024

The FDA issued a Warning Letter to Brassica Pharma Pvt. Ltd. following an inspection from January 15-19, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated.

Key violations include: 1. **Incomplete Laboratory Records (21 CFR 211.194(a)):** The firm failed to ensure complete data. Sterility testing was not performed for all batches, with records fabricated. Environmental and personnel monitoring samples were not collected, and records were fabricated. Four failing sterility tests were observed during the inspection. The firm's data integrity remediation plan was deemed inadequate, lacking a comprehensive retrospective review and broader scope. 2. **Inadequate Aseptic Processing Procedures (21 CFR 211.113(b)):** Poor practices were observed in ISO 5 and ISO 7 areas, including inadequate operator gowning (stained/torn), insufficient media fill programs (lacking intervention documentation and relying solely on color change for growth detection), and inadequate airflow visualization studies (not including set-up or interventions). Bulk drug product sterilization validation was deficient, lacking biological indicators. 3. **Inadequate Facility Design and Environmental Control (21 CFR 211.42(c)(10)):** Aseptic processing equipment design and cleanroom layout were inadequate, with missing equipment parts, aseptic connections performed under