STATEMENT OF FDA ON CONSENT DECREE WITH CENTEON L.L.C.

NEWS 01/28/1997 STATEMENT OF FDA ON CONSENT DECREE WITH CENTEON L.L.C.

STATEMENT                          Contact:  Lenore Gelb
January 28, 1997                             (301) 443-3285
     

                        STATEMENT OF FDA 
              ON CONSENT DECREE WITH CENTEON L.L.C.

     Centeon L.L.C. of King of Prussia, Pa., today agreed in a
consent decree with FDA and the Department of Justice to a series
of measures aimed at bringing their manufacturing standards into
compliance with federal regulations for drug and biological
products.  Until Centeon can demonstrate to FDA that it meets
these safety and quality standards, the company is not allowed to
distribute any of its products in interstate commerce with the
exception of two products, whose continued availability FDA
believes is essential for the public health.
     In the consent decree, Centeon has agreed not to distribute
any drug or biological products from their Bradley, Ill.,
facilities until the following conditions are met:  
     * An outside expert consultant is hired by Centeon to
inspect the facilities and report the status of compliance with
federal regulations.  FDA will also do an independent inspection
to determine whether the company is in compliance with federal
regulations and if so, the company would be allowed by FDA to
release products.             
     *Sufficient numbers of trained company personnel are on
staff to ensure product safety.
     *A comprehensive quality control program is established and
implemented.
     *Standard procedures are developed and implemented to ensure
that adverse reactions to products are promptly and adequately
investigated and when necessary, recalls are promptly conducted.
     *Laboratory controls are established to assure components
used (including product containers and closures) conform to
appropriate standards and that valid testing plans are
established.
     *Building facilities and equipment are maintained to
facilitate proper cleaning, maintenance, and  operation.  This
will include proper water, air, and cleaning systems to assure
that products are free of microbiological contamination. 
     *Records and reports are established and maintained to
document all stages of production and all steps taken to correct
and prevent problems.
     The consent decree requires follow-up inspections by an
outside expert consultant no less frequently than once a year for
four years after the first report, required in October 1997.
     Only two drug products, H.P. Acthar Gel, used to treat
infant seizures, and MVI-12, an injectable multivitamin, will
continue to be manufactured and distributed by Centeon without
interruption because these drugs are considered essential to
public health.             
     On Sept. 23, 1996, Centeon recalled one lot of human
albumin, Albuminar-25, because it was contaminated with bacterial
agents that were associated with reports of septicemia. 
Septicemia is a systemic blood infection which can be life-
threatening.  On Oct. 3, 1996, nine additional lots were recalled
as a precautionary measure.  On Oct. 4, Centeon recalled one lot
of Monoclate-P, an antihemophilic factor used to treat hemophilia
A.  On Oct. 9, Centeon extended the recall to all Albuminar brand
human albumin and Plasma Plex brand plasma protein fraction
(PPF).
     FDA's most recent inspection of Centeon's Bradley, Ill.,
facilities took place from Sept. 27 through Dec. 6.  During this
inspection, FDA documented serious violations of federal
regulations and related standards. 
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