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Executive Summary

BIOCINE SCLAVO WILL REVALIDATE BIOLOGICS MANUFACTURING PROCESSES and submit documentation to FDA for review following the announcement that the company is voluntarily recalling all of its U.S. biological products. The recall was initiated via letter on Sept. 29 after a Sept. 25-29 FDA inspection of the vaccine firm's Siena and Rosia, Italy, manufacturing facilities. The agency conducted the inspection after the company notified FDA of "changes that had previously been made in manufacturing procedures affecting facilities, equipment and processes," an Oct. 27 FDA "Talk Paper" states. A Center for Biologics Evaluation and Research "inspection revealed that the firm had not formally amended its approved licenses to reflect manufacturing changes" to its biological products, the "Talk Paper" explains. All Biocine Sclavo biologics sold in the U.S., including a diphtheria vaccine, a tetanus vaccine and tuberculin skin tests are included in the recall, which is being coordinated out of the firm's U.S. distribution center in Wayne, N.J. A Phase I trial of a recombinant pertussis vaccine begun in the U.S. this year by Biocine Sclavo will not be affected by the recall, Biocine said. FDA anticipates an additional inspection, possibly by the end of the year, of the Italian facilities to determine if there are any problems with Biocine Sclavo's altered manufacturing processes. Biocine said it was Sclavo's former management that did not properly document manufacturing changes "designed to improve the product." The firm contacted FDA in early September, after discovering the problem, the company added. Biocine, a joint vaccine venture of Chiron and Ciba-Geigy, purchased Sclavo SpA's Italian-based biological products business in January of this year as a means of gaining access to new vaccines and to expand its presence in the European market. An agreement in principle was announced last year ("The Pink Sheet" April 15, 1991, T&G-2). Biocine noted that Biocine Sclavo's annual U.S. sales are under $1 mil., compared to sales in Italy of roughly $50 mil. each year. The firm sells an MMR (measles, mumps and rubella) vaccine in Italy as well as its other biologics.

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