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FDA foreign data for current fiscal year find that 68% of actionable inspections involve bulk drugs.

Executive Summary

FDA FOREIGN INSPECTIONS: 68% REQUIRING FURTHER ACTION ARE FOR BULK DRUGS during the current fiscal year, according to data compiled by FDA's international programs staff. About 70% of the inspections performed abroad during this time frame were on bulk facilities and 30% on finished dosage form plants. The inspections, when classified by degree of seriousness of the findings, show a proportional breakdown: 68% of the total number of inspections given FDA's "official action indicated" (OAI) designation -- meaning that follow-up enforcement action is warranted -- were for bulk drugs compared to 32% for finished drugs. Bulk drug inspections comprised 66% of those classified as "voluntary action indicated" (VAI) compared to 34% for dosage forms.

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