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

This FDA Form 483 details significant deficiencies observed during an inspection of a facility manufacturing sterile OTC drug products, specifically Ointment for the US market. The facility performs aseptic filling on Lines 1 and utilizes a sterilization process for the ointment base.

**Key Violations and Observations:**

**Observation 1: Incomplete Laboratory Records and Data Fabrication** * Microbiologists confirmed they do not collect, test, and incubate all required sterility, environmental, and personnel monitoring samples, despite records indicating otherwise. * Sterility tests for multiple batches were documented as performed with "no growth" results, but no samples were present in incubators. The analyst confirmed tests were never performed and records were fabricated. * Personnel monitoring samples were not collected for 73 documented aseptic area entries/exits from January 10-15, 2024, and no entries were made in the logbook from November 5 - December 30, 2023. * Environmental monitoring samples (air, surface, settle plates) were not collected for specified dates, despite being required by procedure MI/009 "Environment Monitoring." * Biometric access records and HR records contradicted documented testing, showing analysts were not present when tests were supposedly performed, including for batches released to the US market.

**Observation 2: Inadequate Validation of Aseptic and Sterilization Processes** * The sterilization process