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This article was originally published in The Gray Sheet

Executive Summary

GMP VIOLATIONS CLASSIFIED AS "SERIOUS" WERE FOUND IN 26% of fiscal year 1992 inspections conducted by the device center's Office of Compliance and Surveillance, OCS Director Ronald Johnson declared at a March 1 Health Industry Manufacturers Association conference in Washington, D.C. The number of serious violations was called "too high" by Johnson, who noted that the percentage of GMP investigations finding serious violations had risen from 17% in 1990 and 21% in 1991. Johnson defined a "serious" violation as having "sufficient GMP problems to the extent that...either a defective product was produced, or that there was a likely chance" that one would be produced. The device center's top enforcement official also noted that 32% of all overseas investigations conducted in 1992 revealed serious GMP violations, prompting a plan to increase the number of foreign inspections conducted this year. "Because of the high number of violations, we've been asked to double the number of foreign inspections that we do this year," Johnson declared. He added: "That is certainly not many, but it is more than...have been done in the past." Johnson explained the high number of violations found in the foreign market as due to OCS' "frontloading the program and preparing the investigators very well." He noted that field investigators assigned to overseas detail are brought to the device center to review all pertinent medical device reports on the company. Subsequently, each investigator is briefed by both OCS' GMP experts and scientists in the office of device evaluation. Johnson further pointed out that "it is not uncommon" for OCS to have reviewed previous inspections to give the investigators "a strategy to follow in particular problem areas." Despite concern over the numbers of GMP violations overall, Johnson said he is "encouraged" by results from the premarket approval inspection program. In 1991, the first year of the program, OCS found 43% of all inspections revealed serious GMP problems; the number dropped to 29% in 1992, according to Johnson. Johnson maintained that one reason for improvement was OCS' involvement in the review of the manufacturing section of a PMA. If problems are found, OCS informs the applicant, so that any problems can be corrected "long before" an investigation occurs. Johnson encouraged all device manufacturers to "do the same thing," and to conduct in-house paper reviews of standard operating practices and procedures to resolve potential GMP violations in advance. Johnson also stated that OCS' plan to broaden the existing PMA review program to include 510(k)s for Class III pre-amendment devices would go into effect " really is getting soon now." Johnson also asserted that "most recalls are caused by GMP problems." In the last fiscal year, 1,330 devices were recalled, according to OCS' annual report for FY 1992. Johnson pointed out that "there are more medical device recalls than any other product recalls that the FDA regulates." The "most struggling aspect," according to Johnson, was the steady increase in recalls: according to the annual report, in FY 1989, 999 devices were recalled; in FY 1990, 934 were recalled; and in FY 1991, the number of recalls rose to 1,128. Also "disturbing," Johnson said, is the increase in the number of MDRs, which rose significantly from "about 16,000 to well over 82,000 in the last year." Johnson attributed the increase to "enhanced enforcement activity," as well as the implementation of three additional mandatory reporting regulations, which became effective in FY 1992. According to the annual report, regulations regarding user facility reporting added over 1,100 documents to the system and 400 semiannual reports, each of which was triaged and entered into the MDR database. Also according to the OCS report, 151 distributor reports were received since the regulation went into effect in May 1992. Johnson noted that looking "at the causes for recalls and MDRs, we have most cases, that the failures can be directly attributed to GMP gaps, lapses, and failures." In FY 1990, 52% of all recalls could be correlated to specific GMP failures, while in 1991 the number slightly decreased to 51%, according to Johnson. However, in the last year, 56% of all recalls were attributed to GMPs. Summing up the opinion of OCS, Johnson said: "It certainly appears to us that poor GMPs significantly contribute in a real way directly to the production of defective products. If you look at various inspection programs that we have" focusing on GMP compliance, "the numbers don't look good."

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