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# Significant Data Integrity Issues at India’s Sri Krishna
- URL: https://www.fdaweb.com/significant-data-integrity-issues-at-indias-sri-krishna/
- Published: 2016-04-19T12:00:00.000Z
- Updated: 2026-09-14T20:55:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135422

> A 12/1-4/14 FDA inspection at Sri Krishna Pharmaceuticals Unit 2 in Hyderabad, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a just-released 4/1 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm495535.htm?ref=fdaweb.com). Specific violations noted during the inspection included:  
> failing to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards; failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel make changes in master production and control records or other records; failing to follow written procedures for production and process control designed to assure that the company’s manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess, and to document same at the time of performance; and failing to establish adequate written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess.  
>  
> The letter says the findings are “serious CGMP violations demonstrating that your quality system does not adequately ensure the accuracy and integrity of the data generated at the facility to support the safety, effectiveness, and quality of the drug products that you manufacture.” FDA noted that it observed similar issues there in 2007\. The letter says that the firm’s response to the inspection violations lacked sufficient corrective action. The agency asked for:  
> a comprehensive investigation into the extent of the inaccuracies in data records and reporting; a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs; and a management strategy for the firm that includes the details of the firm’s global corrective action and preventive action plan.