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.
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