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
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