FDA Takes Action Against Firm for Unsanitary Conditions

The FDA seized more than $300,000 worth of unapproved drugs, dietary supplements and their component ingredients manufactured by St. Louis-based General Therapeutics due in part to grossly unsanitary conditions at the company’s facilities.

During inspections in August and September, FDA inspectors found insects and rodent filth on and around manufacturing equipment, the agency said. The company, which was warned by the FDA for the objectionable conditions in 1999, had told the agency it would stop manufacturing drugs in 2000.

One of the products manufactured by the firm is NC Solution, an antifungal agent. The agency considers the product a new drug because it is not generally recognized as safe and effective. The product was marketed without approval.

The FDA is recommending that anyone taking products manufactured by General Therapeutics consult his or her physician about discontinuing use of the drugs and experiencing any suspect adverse events.