Sicor Implements New Quality Assurance Initiatives

24.07.1999, 14:12

Irvine, Calif. (PROTEXT) - SICOR Inc. (Nasdaq: SCRI) todayannounced that its wholly owned subsidiary, Gensia SicorPharmaceuticals, Inc., has begun implementing new qualityassurance initiatives in response to a Warning Letter receivedfrom the Food and Drug Administration (FDA) relating to a routineinspection conducted in June 1999. The improvement planspecifically responds to observations made by the FDA in theareas of cleaning validation of certain compounding tanks andinformation system data storage. Gensia Sicor Pharmaceuticals has already adopted severalquality improvement measures and anticipates that additionalimprovements to its procedures will be implemented shortly. TheCompany plans to respond to the FDA by the end of July and hopesto resolve this issue as quickly as possible. Manufacturingoperations have not been interrupted and the Company believesthat these enhanced operating procedures will address the FDA'sconcerns and strengthen Gensia Sicor Pharmaceuticals' compliancewith Current Good Manufacturing Practices. SICOR Inc. is a vertically integrated specialty pharmaceuticalcompany with proven expertise in the development, manufacturingand marketing of multi-source injectable pharmaceuticals. With astrategy of combining both the production of activepharmaceutical ingredients utilizing synthesis or fermentationand state of the art manufacturing facilities, SICOR's primaryfocus is on the worldwide injectable pharmaceutical market, whichcurrently includes oncology, anesthesiology, cardiology and othertherapeutic areas. SICOR operates several manufacturingfacilities in Europe, Mexico and the U.S.A., while maintainingthe corporate headquarters in Irvine, California. This press release contains forward looking statements thatare subject to risks and uncertainties that could cause actualresults to differ materially from those set forth in the forwardlooking statements including whether these issues will beresolved; whether the enhanced procedures will address the FDA'sconcerns, and those matters set forth in the risk factors sectionof SICOR's filings on Forms 10-K and 10-Q with the Securities andExchange Commission. These forward looking statements representthe Company's judgment as of the date of this press release. TheCompany disclaims any intent or obligation to update theseforward looking statements. For more information on the Company, visit SICOR's web site atwww.gensiasicor.com. News releases are also available at nocharge through PR Newswire's News On-Call fax service. For a menuof available news releases or to retrieve a specific release madeby SICOR, call 800-758-5804, extension 354050. Please retainthese numbers for future reference. ots Original Text Service:SICOR Inc. Internet: http://www.newsaktuell.de Contact: LaurieW. Little of SICOR Inc. Tel.: (in the USA) 949-455-4879 CompanyNews On-Call: http://www.prnewswire.com/comp/354050.html or fax,800-758-5804, ext. 354050 Web site: http://www.gensiasicor.com

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