Health officials shut Illinois lab over HIV test kits
November 06 2004 1:00 AM ET
The U.S. Food and Drug Administration and the Illinois Department of Public Health have ordered the closing of the lab at Raani Corp. in Bedford Park, Ill., for allegedly manufacturing HIV test kits without a license. A routine fire inspection in October discovered the lab, which had been built without permits inside the company's factory, according to Bedford Park building coordinator Steve Edwards. A search found packages of HIV diagnostic kits and a locked refrigerator containing vials labeled HIV-positive serum, he said. Edward said the U.S. attorney's office is asking local officials to refrain from commenting. FDA deputy regional inspector Andrew Bonanno would only confirm that an investigation is underway.
Raani makes skin lotions and shampoos under contracts for other companies. Company COO Tehsel Dhaliwal said Raani was manufacturing the HIV kits for a client. The FDA said Raani is not on the list of companies licensed to manufacture HIV test kits. Dhaliwal said the company does not need a license because the kits are not sold domestically. FDA officials agreed that a license is not required to produce kits sold outside the United States but said they are investigating other issues at the plant.
Illinois health department spokesman Tom Schafer said Raani "has voluntarily given up the things that were labeled HIV," but added, "I don't know if anybody knows yet what it actually is." Dhaliwal denies that the lab had active virus. He called material on hand "samples" used for "quality control" tests on the effectiveness of the kits. (AP)