The FDA has filed a permanent injunction to stop manufacturing operations at two Wisconsin drug firms. The reason? The continuing failure of certain production standards at the firms that violated federal safety regulations.
One company, H&P commenced five recalls of products, including alcohol-based skin wipes once it was found the wipes had bacterial contamination.
A series of FDA inspections in the past two years found H&P had failed to comply with FDA regulations.
Under the terms of the injunction, H&P will continue to operate its Wisconsin facility as its works with a hired expert to devise a plan for resuming drug production. Any such plan must meet FDA approval.