Contamination leads to consent decree

FDA Consumer, April, 1997 by Dixie Farley

A Pennsylvania manufacturer of a biological product linked to reports of life-threatening blood infections has agreed to stop distributing most of its products until it can meet FDA's manufacturing standards.

Centeon L.L.C., King of Prussia, Pa., signed a consent decree of permanent injunction in January agreeing to stop nearly all distribution at its Bradley, Ill., facilities until it takes corrective actions, including hiring an outside consultant. Bradley is Centeon's only U.S. manufacturing plant.

FDA allowed the company to produce and distribute two products considered essential for the public health--H.P. Acthar Gel treatment for infant seizures and MVI-12 injectable multivitamin.

The consent decree followed a 10-week FDA inspection in which serious violations of federal safety and quality standards were found.

FDA began its investigation Sept. 27, 1996, four days after Centeon recalled one lot--about 17,000 vials--of Albuminar brand human albumin product because it was contaminated with bacteria and linked to reports of septicemia, a life-threatening systemic blood infection.

On Oct. 3, FDA announced that the recall was expanded to include nine additional lots of Albuminar and on Oct. 4 that it also included one lot of Monoclate-P, an antihemophilic factor (Factor VIII) used to treat hemophilia A. Vials in these lots may have been damaged during manufacture and, as a result, could have become contaminated, the agency said. On Oct. 9, as a further precaution, Centeon recalled all its Albuminar human albumin and Plasma Plex plasma protein products.

FDA decided an injunction was necessary to protect the public health, and negotiations between the agency and Centeon began in mid-December.

Under the consent decree, Centeon has agreed to stop distribution (except for the two products) until it:

* hires an outside expert consultant to inspect the facilities, identify Centeon's status of compliance with federal rules, and report this to FDA

* has enough trained staff to ensure product safety

* establishes and implements a comprehensive quality control program

* develops and implements standard procedures to ensure prompt, adequate investigation of adverse reactions and, when necessary, prompt recall of products

* establishes laboratory controls to ensure that product components, including product containers and closures, conform to appropriate standards

* establishes valid testing plans

* properly cleans, maintains and operates the building and equipment, including having proper water, air and cleaning systems, to ensure products are free of microbiological contamination

* establishes and maintains records and reports 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 at least once a year for four years after the first report, required next October.

FDA will inspect Centeon to determine whether it is complying before allowing the company to release products.