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# CGMP Violations Found in Cohance Lifesciences Inspection
- URL: https://www.fdaweb.com/cgmp-violations-found-in-cohance-lifesciences-inspection/
- Published: 2026-02-04T12:00:00.000Z
- Updated: 2026-09-14T15:32:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160604

An 8/4-8/12/2025 FDA inspection at the Cohance Lifesciences drug manufacturing facility in Uppal Mandal, Medchal-Malkajgiri, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/30 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cohance-lifesciences-limited-718812-01302026?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 had already been distributed;
- 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 maintenance of equipment.

FDA says the firm’s responses to the inspection observations were inadequate. The agency acknowledges that Cohance committed to temporarily suspend manufacturing and release of drug products from the facility as of 8/16/2025.

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