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CARDIAC PACEMAKERS, INC. WILL REVISE COMPLAINT PROCESSING PROCEDURES

This article was originally published in The Gray Sheet

Executive Summary

CARDIAC PACEMAKERS, INC. WILL REVISE COMPLAINT PROCESSING PROCEDURES in accordance with a consent decree between the Lilly subsidiary and FDA that was filed on Feb. 17 in the federal district court of Minneapolis, Minnesota. The document states that within 60 days, "CPI shall submit revised written procedures to the Minneapolis District Office of the [FDA] for investigations of complaints and analyses of product failures." The decree states that updated procedures should contain provisions for "complaint records and investigations of complaints" as well as "failure investigations as required by the good manufacturing practices regulations." The procedures must also include "an adequate plan of action promptly to correct any problems found, including a plan for the cessation of distribution of products and recalls of distributed products," the consent decree stipulates. It also requires that CPI's complaint handling and failure investigation records include "corporate laboratory examinations; consultant laboratory examinations; Weibull analyses; and minutes of staff meetings concerning the investigations," the document states. FDA will review the firm's revised procedures and either approve or disapprove them in writing. If the agency disapproves, CPI must further revise the documents and resubmit them within 10 days of its receipt of the disapproval. The decree further states that CPI is subject to civil penalties in the amount of $5,000 for each day the documents are overdue. CPI says the consent decree is the result of year-long discussions with FDA about GMP violations related to the firm's complaint handling and product failure investigation procedures at its St. Paul manufacturing facility. The discussions began in late 1991, around the time CPI conducted a recall of 85 of its Vista T and Astra T single chamber pacemakers due to chip capacitor failures ("The Gray Sheet" Feb. 10, 1992, p. 13). The late 1991 recalls were among several that CPI has undertaken over the last two years. Vista pacers were recalled in December 1990 following reports of rapid battery depletion; in February 1991, the firm's Delta pacers were recalled for the same reason. In April 1992, the Ventak implantable defibrillator was subject to a recall because of potential diode contamination. Under the consent agreement, FDA is authorized to inspect CPI's facilities, equipment, materials, products and labeling and to "take photographs, and to examine and copy all records relating to the receipt, manufacturing, processing, packing, labeling, promotion, holding, and distribution of any of CPI's products." The company is obligated to reimburse FDA for the inspections and any laboratory work. If, as the result of an inspection, FDA informs the firm that it is out of compliance with GMPs, "CPI shall immediately cease distributing and dispensing any article of device." Distribution would be resumed after a satisfactory FDA inspection. The decree states that "at CPI's request, the government shall cooperate with CPI in seeking expedited review of any decision by FDA under this decree." Finally, the decree states that within three business days CPI must pay the United States $500,000 "to reimburse the government for the costs of its investigation." After three years, the company may petition the court for dissolution of the agreement, and FDA may choose to oppose the petition at its discretion.
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