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# CGMP Violations in Somerset Therapeutics Inspection
- URL: https://www.fdaweb.com/cgmp-violations-in-somerset-therapeutics-inspection/
- Published: 2025-09-16T12:00:00.000Z
- Updated: 2026-09-14T15:21:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159873

A 2/10-2/21 FDA inspection at the Somerset Therapeutics Private Limited drug manufacturing facility in Bengaluru, Karnataka, India, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/4 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/somerset-therapeutics-private-limited-711340-09042025?ref=fdaweb.com) says the specific violations were:

- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failure to establish an adequate system for maintaining equipment used to control the aseptic conditions; and
- failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

The letter also identifies a Field Alert Reporting violation related to a 9/2024 aseptic processing simulation failure that was not provided to FDA within three working days.

Somerset was told to correct the 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.