FDA Cites Irvine Firm for Unapproved Tests

Worldwide Medical Corp. of Irvine was cited by the Food and Drug Administration for allegedly selling tests that check for drug use without agency approval. The FDA is seeking a total of $3.29 million in fines from Worldwide Medical and its current and former executives, according to an administrative complaint filed by the agency. The tests are sold over the counter for $12.99 to $29.99 and screen urine for marijuana, cocaine and heroin, Worldwide Chief Executive Daniel McGuire said. Worldwide Medical received FDA approval to sell the kits on June 23, and the complaint relates to sales between July 1999 and June 2000, when the company was seeking approval, the agency and company said. “It has nothing to do with our current business or our current product line,” McGuire said. “All of our products are FDA compliant.” The agency is seeking $1 million in civil penalties from the company; $1 million from former CEO H. Thad Morris; $840,000 from Patti Evanoff, former interim president and current board member; and $450,000 from McGuire, according to the complaint. The company has 30 days to request a hearing before an administrative judge. Worldwide shares rose 3 cents to close at 33 cents in over-the-counter trading.