RE:USA Inflation Reduction Act (IRA) 2022 Re: Biotech and ChinaJuly 24, 2024 - FDA blasted Indian CDMO Brassica for 'routine' data falsifications, poor hygiene, and more ....
" From flubbing data to performing aseptic processing with torn and stained gowns, Brassica Pharma’s recent warning letter from the FDA reads like a textbook example of what not to do when the U.S. regulator comes knocking at your facility."
"Brassica’s manufacturing slights run the gamut from widespread and routine data falsification to substandard environmental monitoring meant to ensure the sterility of drugs, according to the FDA’s July 11 warning letter, which was published Tuesday." The warning letter starts off innocently enough, noting that Brassica failed to test every batch of its drug products for sterility.
Things took a turn when the FDA interviewed Brassica’s “sole analyst” trained in the testing procedures, who revealed that it was his “routine practice” to not test all batches and fabricate records for samples not tested.
To make matters worse, during the inspection, the FDA observed four failed sterility tests, including one for a U.S.-bound product.
Brassica also failed to collect samples for environmental and personnel monitoring. Once again, interviews with the company’s microbiology staff revealed that it’s Brassica’s “routine practice to fabricate records and results for samples that were not taken,” the FDA said."
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/brassica-pharma-pvt-ltd-679005-07112024 The FDA's warning leter read : ... "The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Brassica Pharma Pvt. Ltd., FEI 3014129013, at Plot No. T-68, T 68 (Pt), T-63, Midc, Tarapur, Boisar, Thane from January 15 to 19, 2024. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).:
During our inspection, our investigators observed specific violations including, but not limited to, the following.
1. 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)).
2. 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)).
3. 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)).
4. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and 211.67(b)).