Sicor Implements New Quality Assurance Initiatives

24.07.1999, 14:12

Irvine, Calif. (PROTEXT) - SICOR Inc. (Nasdaq: SCRI) today announced that its wholly owned subsidiary, Gensia Sicor Pharmaceuticals, Inc., has begun implementing new quality assurance initiatives in response to a Warning Letter received from the Food and Drug Administration (FDA) relating to a routine inspection conducted in June 1999. The improvement plan specifically responds to observations made by the FDA in the areas of cleaning validation of certain compounding tanks and information system data storage. Gensia Sicor Pharmaceuticals has already adopted several quality improvement measures and anticipates that additional improvements to its procedures will be implemented shortly. The Company plans to respond to the FDA by the end of July and hopes to resolve this issue as quickly as possible. Manufacturing operations have not been interrupted and the Company believes that these enhanced operating procedures will address the FDA's concerns and strengthen Gensia Sicor Pharmaceuticals' compliance with Current Good Manufacturing Practices. SICOR Inc. is a vertically integrated specialty pharmaceutical company with proven expertise in the development, manufacturing and marketing of multi-source injectable pharmaceuticals. With a strategy of combining both the production of active pharmaceutical ingredients utilizing synthesis or fermentation and state of the art manufacturing facilities, SICOR's primary focus is on the worldwide injectable pharmaceutical market, which currently includes oncology, anesthesiology, cardiology and other therapeutic areas. SICOR operates several manufacturing facilities in Europe, Mexico and the U.S.A., while maintaining the corporate headquarters in Irvine, California. This press release contains forward looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those set forth in the forward looking statements including whether these issues will be resolved; whether the enhanced procedures will address the FDA's concerns, and those matters set forth in the risk factors section of SICOR's filings on Forms 10-K and 10-Q with the Securities and Exchange Commission. These forward looking statements represent the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward looking statements. For more information on the Company, visit SICOR's web site at www.gensiasicor.com. News releases are also available at no charge through PR Newswire's News On-Call fax service. For a menu of available news releases or to retrieve a specific release made by SICOR, call 800-758-5804, extension 354050. Please retain these numbers for future reference. ots Original Text Service: SICOR Inc. Internet: http://www.newsaktuell.de Contact: Laurie W. Little of SICOR Inc. Tel.: (in the USA) 949-455-4879 Company News On-Call: http://www.prnewswire.com/comp/354050.html or fax, 800-758-5804, ext. 354050 Web site: http://www.gensiasicor.com Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. Protext is a commercial service providing distribution of press releases from clients, who are identified in the text of Protext reports and who bear full responsibility for their contents. PROTEXT

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