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FDA inspection of indian drug manufacturer

FDA Scolds Indian Drugmaker over Contaminated Equipment

July 17, 2017
Upon a recent inspection of the facilities of Indian drug manufacturer Vista Pharmaceuticals, the U.S. Food and Drug Administration (FDA) discovered a fragment of metal in a pill, as well as corroded manufacturing equipment.

The FDA reported in a formal warning letter to Vista that three pieces of equipment in its lab suffered from corrosion and deterioration. The letter demanded a re-evaluation of all of Vista’s equipment, as well as a survey of all extant medications, should the company wish to continue to do business in the U.S.

An additional problem for the Hyderabad-based drug manufacturer is that the FDA found that the isoxsuprine hydrochloride manufactured by Vista is substantially identical to a drug called Vasodilan, which is currently under scrutiny by the FDA in a drug efficacy study. Vasodilan was pulled from circulation by the FDA in 2009, and Vista’s version of the medication is not currently slated for undergo the FDA approval process.

If you believe that the drugs you’ve been prescribed are dangerous, contaminated, or otherwise hazardous, TheLawFirm.com wants to hear from you. Call us today for a free consultation.

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