Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.
PRNewswire - Friday December 1, 2000
The government contends that during the period December 1995 to July 21, 1998, the Rapid HIV Test Kits were introduced into interstate commerce in an adulterated form within the meaning of Title 21 United States Code, Section 351(h) in that the devices had not been manufactured, tested, stored, packaged, and distributed in accordance with current good manufacturing practices and were distributed without "approvals" and "clearances" from the Food and Drug Administration.
SMLX shut down production of the Rapid HIV Test Kit when the FDA began questioning the legitimacy of the product. The individuals allegedly responsible for these actions have resigned as officers and directors of the company and each has been served with an "Information" by the government investigation.
Ken Robertson, who was appointed president of the company in October 2000, said, "The Company has been cooperating fully with the government and obviously wants to put this matter behind it. We knew there was some kind of problem, but we didn't find out the full scope of it until the third quarter of 2000." The company will continue to cooperate with the government and expects to conclude this matter in an appropriate fashion.
SOURCE: SMLX Technologies, Inc.
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