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Executive Summary

FDA FOREIGN INSPECTION PROGRAM GOAL IS BACKLOG ELIMINATION IN FY 1993, FDA International Program and Technical Support Branch (IPTSB) Director Richard Klug said March 17 at an ISPE conference in Bethesda, Md. Klug told members of the International Society for Pharmaceutical Engineering that the backlog of 220 foreign inspections as of Oct. 1, 1992 already has been "reduced greatly" in the first five months of fiscal 1993 to 154 inspections pending. With the program's expanded moneys, FDA also hopes to increase the frequency of routine reinspections of foreign firms to at least every two to three years. The agency is stepping up its foreign inspection program using increased funds and human resources assigned to the program last autumn ("The Pink Sheet" Sept. 28, 1992, T&G-5). As part of its beefed-up inspection program, FDA "will use more aggressive action against fraud" at foreign firms, Klug said. "We are starting to find, as we are looking at more firms and doing more comprehensive inspections, fraud in foreign firms also," Klug explained. IPTSB has requested that an ad hoc committee be assembled to determine how FDA will deal with fraud at foreign companies. FDA "may very well approach the Department of Justice for extradition [of] some individuals and some firms if we feel that's necessary to correct the problem and make an example of some firms." Validation is one of the areas where foreign firms encounter the most problems, Klug noted. At the University of Georgia GMP conference, FDA Mid-Atlantic Region Director Richard Davis explained that process validation will be a focal point in the agency's enforcement crackdown on bulk drug manufacturing practices (see related story, p. 12). Bulk suppliers currently make up about 60% of the firms FDA inspects abroad. The agency is projecting that it will perform between 250 and 360 foreign drug inspections in FY 1993, compared to 184 in FY 1992. The limiting factor is expected to be funds rather than the number of inspectors. At a meeting on Good Manufacturing Practices at the University of Georgia in Athens March 18, IPTSB Deputy Director Peter Smith noted that through efficient scheduling, the program is hoping to perform at least 300 inspections. Funds for foreign inspections in FY 1993 are $1.7 mil., more than double the prior year's allotment of $750,000. However, IPTSB estimated in September that it needed $2.5 mil. to complete anticipated inspections. The program now has 220 active foreign inspectors and analysts, compared to 60 last year. IPTSB held training courses for its new inspectors, who already have experience with domestic inspections, in September 1992 and in February of this year. The office is holding another course in Dallas the week of March 22, after which it will have trained 150 new investigators. The balance will be trained through accompanying experienced inspectors in the field.

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