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Alpha Therapeutic in Pact With Regulators

January 28, 1998|Bloomberg News

Los Angeles-based Alpha Therapeutic Corp., a blood products unit of Japan's Green Cross Corp., agreed to hire an outside consultant and beef up its quality control practices in a consent decree with U.S. regulators to be filed in federal court. The Food and Drug Administration said it and the Justice Department pursued the decree after inspectors repeatedly found problems with the company's manufacturing standards and testing procedures. The FDA said the consent decree requires Alpha Therapeutic to strengthen its quality control programs, evaluate its management structure to make sure the company can comply with FDA regulations, fix its internal audit system and improve its record-keeping, among other things. The agency said the actions won't affect the continued sale of the company's products. Company officials said the decree was part of the FDA's effort to intensify its oversight of the blood products industry.

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