FOR IMMEDIATE RELEASECIV
MONDAY, JUNE 19, 2000(202) 514-2007
WWW.USDOJ.GOVTDD (202) 514-1888
CALIFORNIA COMPANY AGREES TO STOP MANUFACTURING
IN-VITRO DIAGNOSTICS TEST KITS
WASHINGTON, DC - Cal-Test Diagnostics, Inc. has signed an agreement to stop making and selling its in-vitro diagnostic test kits until it corrects long-standing manufacturing problems and receives clearance from the Food and Drug Administration (FDA) for these products, the Justice Department announced today. The consent decree was signed by Judge Christina A. Snyder in U.S. District Court in Los Angeles.
The Chino, California company makes numerous types of in-vitro diagnostic test kits, including several types of HIV, hepatitis and pregnancy tests. The company's products are sold to laboratories, medical facilities and distributors around the world.
Over the past four years, Cal-Test has failed to comply with FDA's Current Good Manufacturing Practice and Quality Systems regulations and has sold its test kits without prior FDA clearance. The manufacturing deficiencies affected Cal-Test's methods and controls used to manufacture, pack and store the test kits, and also impacted the performance of the products.
Under the consent decree Cal-Test will destroy all of its inventory and stop marketing and distributing its products until all test kits have been cleared by FDA and all manufacturing deficiencies have been corrected. FDA will supervise destruction of the inventory.
Cal-Test will be allowed to resume operations once FDA is satisfied that the company is in compliance with the law. Cal-Test will reimburse FDA for all costs related to supervision, inspections, record reviews, examinations and analyses conducted under the consent decree.
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