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A bum rap from FDA's FACTS database

This article was originally published in The Gold Sheet

Executive Summary

One reason some foreign drug manufacturing facilities get a bad rap at FDA is that they are unfairly maligned by the agency's information systems, according to the General Accountability Office, an investigational arm of Congress. FDA's Office of Regulatory Affairs decides based on inspection findings whether it believes there are any problems that require fixing. If none, it reports "no action indicated." Otherwise, it reports either "voluntary action indicated" or "official action indicated." An OAI finding is the most serious, and can lead to warning letters and other unpleasantries. ORA officials report their recommended classifications in the agency's Field Accomplishments and Compliance Tracking System (FACTS) database, which is available to ORA and all the FDA centers. Officials with the Center for Drug Evaluation and Research later make final classification decisions and enter those into the Office of Compliance Foreign Inspection Tracking System (OCFITS) database, to which only CDER officials have access. When GAO compared foreign inspection findings in the two databases, it found that 53 percent of the OAI findings had been downgraded to VAI in OCFITS. However, when ORA investigators and staff from other FDA centers check an establishment's compliance history, they look only in the FACTS database. See page 30 of GAO-08-970, "Better Data Management and More Inspections are Needed to Strengthen FDA's Foreign Drug Inspection Program.



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