> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Brassica Pharma CGMP Violations
- URL: https://www.fdaweb.com/brassica-pharma-cgmp-violations/
- Published: 2024-07-23T12:00:00.000Z
- Updated: 2026-09-14T14:36:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157409

A 1/15-1/19 FDA inspection at the drug manufacturing facility operated by Brassica Pharma Pvt. Ltd. in Thane, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 7/11 Warning Letter says specific violations were:

- failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
- failure 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; and
- failure 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, and failure to establish and follow adequate written procedures for cleaning and maintaining equipment.

The letter says the firm’s responses to the inspection observations were inadequate. FDA acknowledges Brassica’s commitment to suspend manufacturing and distribution of all drugs for the U.S. market and to recall all drugs currently in distribution in the U.S. If it plans to resume manufacturing drugs for the U.S. market, the letter says, Brassica is responsible for resolving all deficiencies and systemic flaws to ensure it is capable of ongoing CGMP compliance. The company was placed on a 1/30 Import Alert.

The agency recommends that the company engage a qualified consultant to evaluate its operations, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of its corrective and preventive actions.

Brassica was told to correct any violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.