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Foreign bulk ingredient plants have 17% non-compliance rate following FDA inspections.

This article was originally published in The Tan Sheet

Executive Summary

FOREIGN BULK PLANT INSPECTIONS HAVE 17% GMP NON-COMPLIANCE RATE over a two-year period. Of the 368 inspections of active pharmaceutical ingredient manufacturers in the two years, 61 (17%) resulted in non-compliance letters from FDA compared to 16 (11%) of the 152 inspections conducted in finished product plants, according to a survey of agency compliance letters sent to foreign companies between FY 1995 and FY 1996.
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