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# CGMP Violations at Granules India Limited
- URL: https://www.fdaweb.com/cgmp-violations-at-granules-india-limited/
- Published: 2025-03-04T12:00:00.000Z
- Updated: 2026-09-14T14:54:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158756

An 8/26-9/6/2024 FDA inspection at the Granules India Limited drug manufacturing facility in Gagillapur Village, Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/26 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/granules-india-limited-697115-02262025?ref=fdaweb.com) says the specific violations were:

- failure to establish and follow adequate written procedures for cleaning and maintaining equipment;
- failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair; and
- failure to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product.

The letter says the firm’s responses to the three observations were inadequate. It also expresses the agency’s concern that a large amount of torn CGMP records was discovered in at least 15 plastic waste bags during the inspection, including analytical balance printouts and worksheets containing manufacturing and testing data. “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the letter says.

Granules 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.