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LYPHOMED GRAND ISLAND, N.Y. PLANT FD-483 INSPECTION REPORT

Executive Summary

LYPHOMED GRAND ISLAND, N.Y. PLANT FD-483 INSPECTION REPORT: potential cephalosporin cross-contamination was cited by FDA in a lengthy adverse findings report issued Sept. 9 following completion of a month-long inspection of the facility. The report states that LyphoMed's "procedures to prevent cephalosporin contamination of non-cephaphosporin parenteral products" also manufactured at the facility "were inadequate." Cephalosporins manufactured by LyphoMed at Grand Island include cefazolin, cephalothin and cephapirin. DFDA noted specifically that "sterile cephalosporins and other parenterals were filled in the same building with employees utilizing a common hall for entrance to their respective filling rooms," and that cephalosporins "were routinely weighed in the formulation area for non-cephalosporin products." The FD-483 adds that LyphoMed did not perform adequate testing of the environment outside the filling room or of the non-cephalosporin products for potential cephalosporin contamination. In addition to inadequate precautions against cross-contamination in the Grand Island plant, the Sept. 9 FD-483 also cited LyphoMed for other aspects of its cephalosporin production, including: incomplete stability testing, failure to conduct media fill validation of aseptic processing, and incomplete validation of the autoclave process, vial washing system, and analytical methods. GMP problems were also cited involving other injectables manufactured at the plan, including: sodium chloride, heparin, dexamethazone and hydroxyzine. Grand Island is the third LyphoMed plant to run into inspection problems with FDA. LyphoMed's plant at Melrose Park, Ill. is operating at reduced capacity following a series of adverse inspection findings by FDA over the past year. Adverse GMP findings at the firm's Orlando facility in June led to the halting of production at the plant and FDA's seizure of LyphoMed's Orlando product inventory. LyphoMed and the U.S. Justice Department announced on Sept. 13 that a consent agreement had been reached with FDA establishing terms for the handling of the seized products and a lot of potassium chloride from Orlando recalled by the firm in July. The agreement sets up terms for the release and reconditioning of the terminally sterilized products involved in the seizure action, including a sterility control checklist to be reviewed by the agency before the products can be distributed. According to the agreement, all aseptically filled products seized by FDA and all of the recalled potasium chloride are to be destroyed by LyphoMed. The Justice also called for Lyphomed to post a $ 3.4 mil. bond subject to the firm's successful completion of the terms of the agreement. The agreement further states that the Orlando plant "may not reopen" until inspected and cleared by FDA. LyphoMed also announced on Sept. 15 that former American Hospital Supply executive Gary Nei will become president and chief operating officer of the company effective Nov. 1. John Kapoor will continue as chairman and CEO. Nei served as an executive at AHS and Baxter-Travenol before leaving to head NPI, a Salt-Lake City-based biotech company in 1987. Another recent change in LyphoMed management was the resignation of Roland Catherall. Catherall had joined LyphoMed as regulatory affairs director in March as part of LyphoMed's overall effort to upgrade its quality assurance program. However, Catherall departed for Abbott Labs last month.

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