FDA Reams Out Indian CDMO Brassica for Falsifying Data and Bad Hygiene
August 1st, 2024 // 8:41 pm @ jmpickett
Indian CDMO was heavily criticized by FDA in a recent warning letter for falsifying data, doing aseptic processing with dirty and torn gowns, and more. The FDA warning letter to Brassica Pharma was essentially a not-to-do list when an FDA inspector comes for a visit.
After the FDA inspected the firm’s Tarapur manufacturing facility in Maharashtra, India, in January 2024, the agency delivered a brutal warning letter with four serious violations. Brassica had already gotten a slap on the wrist from FDA in a 483 in late 2023.
Brassica’s manufacturing flaws included regular falsification of data, as well as improper environmental monitoring that is supposed to ensure drug sterility, according to the July 11 FDA warning letter.
The FDA cGMP violations were serious, and the agency has advised the company to hire a manufacturing consultant. The company promised to stop manufacturing and distribution of all products being sent to the US after the FDA inspection.
FDA discovered during the inspection that Brassica employed just one analyst for testing procedures. He revealed that he regularly didn’t test every batch and fake records for the ones he didn’t test. FDA also saw at least four failed sterility tests during the FDA audit.
When responding to the falsification of data observation, Brassica said it would investigate and design a code of conduct to ensure data integrity. The internal probe didn’t perform a retrospective review of every dataset recorded. Nor did it include a review of every data recording practice that was done outside of their microbiology laboratory.
FDA also criticized the company because it saw line employees touching the interior of empty sterile tubes. Gowning that employees wore during the aseptic processing procedures was torn and stained, too.
Before the company can start to resume drugs for the US market, it must fix all systemic and deficiencies FDA found. It also must meet all current US cGMPs for drug quality. Brassica produces sterile eye ointments and gels, prefilled syringes, dermatologicals and liquid orals,
