FDA FOREIGN DRUG INSPECTIONS COMPLETED AT APPROXIMATELY 300 COMPANIES

FDA FOREIGN DRUG INSPECTIONS COMPLETED AT APPROXIMATELY 300 COMPANIES during fiscal 1993 (ended Sept. 30), Office of Regional Operations International Programs and Technical Support Branch (IPTSB) Director Richard Klug told the FDA/Parenteral Drug Association 1993 Joint Conference in Bethesda, Md. on Sept. 27. The 300 inspections completed at foreign drug companies' manufacturing facilities in the last 12 months is up from 184 inspection in FY 1992. As of Sept. 15, Klug reported, FDA had finished 228 inspections of foreign drug manufacturing facilities and 55 biologics plants. The number of inspections by the end of the fiscal year would probably top 300, Klug predicted. The Center for Drug Evaluation & Research assigned 325 inspections involving 134 ANDAs, 125 NDAs and 19 INDs to the IPTSB in FY 1993, FDA Investigator Charles Edwards said. About 59% of the inspections were for bulk pharmaceuticals, 19% for finished dosage forms and 22% for veterinary, biologic and bioresearch products. Upgrading the foreign inspection program was targeted as an FDA priority for FY 1993. The agency earmarked additional resources and made administrative and management changes designed to intensify the program. The immediate goal was to reduce a backlog of about 200 pending preapproval inspection assignments while addressing an increasing number of inspection requests coming from agency centers. FDA is planning to increase its total number of foreign inspections for drugs, biologics, food, devices and blood banks from 800 to 1,100 in FY 1994, Klug reported. Since Oct. 1, 1992, the backlog of preapproval drug and biologics inspection assignments has been cut from 220 to 129, Klug reported. He noted that 78 of those inspections have been pending for six months or less and many of the assignments over 12-months-old involve firms that are not ready to be inspected. Klug maintained that the backlog is "really not a backlog at all." FDA is planning to expand the number of plant-wide good manufacturing practices inspections conducted at foreign facilities during FY 1994. The successful elimination over the past year of the backlog has created room for the agency to catch up on routine GMP reinspections at foreign plants. Bulk manufacturers make up a significant majority of firms falling under FDA purview abroad and will be the primary focus of the increased routine inspection coverage. However, foreign dosage form manufacturers that have not received a plant-wide GMP review recently also may be visited by FDA investigators. As a general rule, over the past few years FDA has not reinspected firms that are shipping products to the U.S. unless they have been listed on pending applications. In those cases, many of the inspections have been limited to a single product and the specific process involved. In FY 1994, FDA's IPTSB projects that the foreign program will be conducting more general- facilities GMP inspections in addition to product-specific inspections. The IPTSB is developing a list of all foreign manufacturers that have not been inspected since 1990. Some of these will be found to be inactive or to have become part of other companies. FDA's intent is to start with the active firms that have gone the longest without inspection coverage and work forward. General GMP audit assignments will be piggy-backed onto preapproval inspection trips to the same geographic location to minimize investigator travel time and expense. Over the past year, FDA has increased its cadre of active foreign inspectors and analysts to about 220 from a pre-1992 level of about 65-70. Klug said that approximately 40% of foreign inspections require an investigator and analyst team, as opposed to an investigator alone. IPTSB estimates that if it were to receive an assignment for a preapproval inspection today, it could be completed within two to four months.