FDA again warns that Texas compounder's products may not be sterile

The FDA continues its battle with a Dallax, TX, compounding pharmacy which it says is not meeting sterility standards. The FDA has sent a notice to healthcare providers not to use products manufactured by NuVision Pharmacy. The agency linked to the notice a Form 483 from a recent inspection which includes 13 observations. The agency says that 19 lots failed sterility testing but the company did not investigate the cause. When the FDA sent a similar notice last year, the company notified customers that it did not believe it was bound by FDA regulations or oversight. It said it had its products tested by an outside lab for sterility. A notice on the NuVision website now says the company was acquired by Downing Labs of Dallas in January and that it was working to meet FDA standards for compounding pharmacies. Notice | More