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# CGMP Violations at India’s Vista Pharmaceuticals
- URL: https://www.fdaweb.com/cgmp-violations-at-indias-vista-pharmaceuticals/
- Published: 2017-07-11T12:00:00.000Z
- Updated: 2026-09-14T22:33:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139098

A 9/19-23/16 FDA inspection at Vista Pharmaceuticals, Nalgonda, Telangana, India, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to a 7/5 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm565861.htm?ref=fdaweb.com). The letter also says that an agency review of labeling provided by the company determined that its isoxsuprine hydrochloride 20 mg tablets is misbranded. Specific CGMP violations observed by the investigators were: 

- failing 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
- failing to establish written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess.

According to FDA, the firm’s isoxsuprine hydrochloride tablets appear to be identical, related, or similar to Vasodilan tablets, which are the subject of a pending Drug Efficacy Study Implementation proceeding. Approval for the Vasodilan NDA was withdrawn 3/13/09, FDA says, and there is no FDA approved application on file for the Vista product.

Vista was told to respond with a list of steps it has taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion.