An Indian drugmaker whose equipment was rusted has been busted.
The FDA has issued a warning letter to Vista Pharmaceuticals after an inspection last year found it was using corroded equipment and producing meds that had never been validated. It is the second warning letter for the company, which in 2015 was cited for not paying PDUFA fees for one of its plants.
The letter, posted Tuesday, says that last year the FDA decided to take a look at the Vista plant in Hyderabad, Telangana, after getting a complaint of metal embedded in one of the drug tablets Vista had shipped to the U.S.
When investigators did their September 2016 walk-through, they noticed three pieces of equipment that had corrosion and holes, including equipment used for compression. The FDA said that when Vista investigated the complaint about the metal-tainted tablet, it didn’t even consider that the rusted equipment might have been the source of the problem.
The company told the FDA that it has replaced the equipment, but the FDA wants more. It told the company it needs to do a retrospective review of all of the meds produced with that old equipment, including isoxsuprine hydrochloride tablets that the FDA was particularly troubled about.
The drugmaker has told the FDA that it is no longer producing isoxsuprine hydrochloride. But the FDA learned that Vista had never performed process validation for the batches it shipped to the U.S. from 2014 to 2016.
The FDA says Vista never got the drug approved. It also pointed out that its 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. The FDA said that it has learned of some adverse event cases that may be associated with use of isoxsuprine hydrochloride.