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Highlights

Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) efforts to correct problems identified in earlier evaluations of its foreign drug inspection program, focusing on FDA's efforts to: (1) prepare inspection reports and take enforcement actions against foreign pharmaceutical manufacturers in a timely manner; (2) improve the consistency with which FDA evaluates the results of foreign inspections and conducts reinspections to verify that foreign pharmaceutical manufacturers have corrected serious deficiencies; (3) conduct routine inspections of foreign pharmaceutical manufacturers to monitor their compliance with U.S. quality standards; and (4) improve the management of data needed for planning inspections, monitoring inspection results, and taking enforcement actions.

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Recommendations

Recommendations for Executive Action

Agency Affected Recommendation Status
Food and Drug Administration 1. To improve the effectiveness of FDA's foreign inspection program to ensure that only safe, pure, and high quality drugs are imported into the United States, the Commissioner of FDA should ensure that serious manufacturing deficiencies are promptly identified and enforcement actions are initiated by requiring investigators to prepare inspection reports and the Center for Drug Evaluation and Research to issue warning letters within established time periods.
Closed - Implemented
The Associate Commissioner of FDA issued a directive to district managers emphasizing their responsibility for ensuring that established time frames for submitting inspection reports are met. CDER has also been given two additional FTEs specifically for working on foreign drug inspections.
Food and Drug Administration 2. To improve the effectiveness of FDA's foreign inspection program to ensure that only safe, pure, and high quality drugs are imported into the United States, the Commissioner of FDA should reexamine and revise FDA's foreign inspection strategy to provide adequate assurance that all foreign manufacturers exporting approved pharmaceutical products to the United States comply with U.S. standards. At a minimum, the strategy should include: (1) timely follow-up inspections of all foreign manufacturers that have been identified as having serious manufacturing deficiencies and that promised to take corrective action; and (2) periodic surveillance inspections of all foreign pharmaceutical manufacturers, not just high-risk manufacturers.
Closed - Implemented
Although FDA is checking the OASIS data base to identify foreign pharmaceutical manufacturers that have not received a periodic surveillance inspection, FDA does not intend to reassess its foreign inspection strategy until some unspecified time in the future. Moreover, FDA does not intend to reinspect all foreign manufacturers identified as having serious manufacturing deficiencies and that promised to take corrective action. Based on recent discussions, FDA is not expected to take any further action on this recommendation.

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