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# Brassica Pharma Hit with 10-item FDA-483
- URL: https://www.fdaweb.com/brassica-pharma-hit-with-10-item-fda-483/
- Published: 2024-07-26T12:00:00.000Z
- Updated: 2026-09-14T14:36:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157443

A January inspection of Brassica Pharma’s sterile drug manufacturing facility in Maharashtra, India resulted in a just-posted 10-observation [Form FDA-483](https://www.fda.gov/media/180327/download?ref=fdaweb.com) that cited significant GMP violations. For example, agency investigators said the firm’s lab records did not include complete data derived from all tests and examinations necessary to assure compliance with established specifications and standards. The agency inspection also cited Brassica’s aseptic and sterilization processed for not having an adequate validation. Additionally, FDA found that the firm’s laboratory controls do not include scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.