Recommendations Database

GAO’s recommendations database contains report recommendations that still need to be addressed. GAO’s priority recommendations are those that we believe warrant priority attention. We sent letters to the heads of key departments and agencies, urging them to continue focusing on these issues. Below you can search only priority recommendations, or search all recommendations.

Our recommendations help congressional and agency leaders prepare for appropriations and oversight activities, as well as help improve government operations. Moreover, when implemented, some of our priority recommendations can save large amounts of money, help Congress make decisions on major issues, and substantially improve or transform major government programs or agencies, among other benefits.

As of December 7, 2021, there are 4642 open recommendations, of which 482 are priority recommendations. Recommendations remain open until they are designated as Closed-implemented or Closed-not implemented.

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1 - 4 of 4 Recommendations
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COVID-19: Critical Vaccine Distribution, Supply Chain, Program Integrity, and Other Challenges Require Focused Federal Attention

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1 Open Recommendations
1 Priority
Agency Recommendation Status
Food and Drug Administration
Priority Rec.
This is a priority recommendation.
The Commissioner of the Food and Drug Administration should, as inspection plans for future fiscal years are developed, ensure that such plans identify, analyze, and respond to the issues presented by the backlog of inspections that could jeopardize the goal of risk-driven inspections. (Recommendation 4)
Open

FDA concurred with our recommendation and stated that it is actively tracking the list of sites that need to be inspected. In June 2021, FDA reported that it was tracking the list of establishments in need of inspection on a quarterly basis and reiterated that the agency continued to use alternative tools to oversee manufacturing quality while inspections are paused. In August 2021, FDA noted that its May 2021 Resiliency Roadmap for FDA Inspectional Oversight outlined the agency's inspection related activities during the COVID-19 pandemic, including its inspection priorities going forward. In

Imported Seafood Safety: FDA and USDA Could Strengthen Efforts to Prevent Unsafe Drug Residues

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1 Open Recommendations
1 Priority
Agency Recommendation Status
Food and Drug Administration
Priority Rec.
This is a priority recommendation.
The Commissioner of FDA should coordinate and communicate with FSIS in developing drug residue testing methods and corresponding maximum residue levels for imported seafood that may also be applicable to imported catfish. (Recommendation 4)
Open

FDA agreed with this recommendation. According to FDA officials, the agency shared its testing methods for two drugs with FSIS and as of as of April 2019, FSIS and FDA were using the same method for measuring and confirming these two unapproved drugs. In August 2020, FDA told GAO that the agencies convene quarterly to discuss emerging and ongoing research needs in laboratory method development and the establishment of drug residue limits in seafood. We commend FDA and FSIS for taking these steps to share information on testing methods. However, GAO found that the agencies continue to use

Drug Safety: FDA Has Improved Its Foreign Drug Inspection Program, but Needs to Assess the Effectiveness and Staffing of Its Foreign Offices

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1 Open Recommendations
1 Priority
Agency Recommendation Status
Food and Drug Administration
Priority Rec.
This is a priority recommendation.
To help ensure that FDA's foreign offices are able to fully meet their mission of helping to ensure the safety of imported products, as the agency continues to test performance measures and evaluate its Office of International Programs (OIP) strategic workforce plan, the Commissioner of FDA should assess the effectiveness of the foreign offices' contributions by systematically tracking information to measure whether the offices' activities specifically contribute to drug safety-related outcomes, such as inspections, import alerts, and warning letters.
Open

In June and July 2018 FDA reported on its recent efforts to assess the effectiveness of the foreign offices' contributions to drug-safety related outcomes. These efforts include the development of new performance measures for these offices along with a monitoring and evaluation plan; strengthened communications and collaboration between the foreign offices and FDA program centers and its Office of Regulatory Affairs; and an assessment of the foreign offices to help set their objectives and ensure the right balance of personnel, skillsets, and resources. However, FDA still had to develop

Food Safety: Additional Actions Needed to Help FDA's Foreign Offices Ensure Safety of Imported Food

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1 Open Recommendations
1 Priority
Agency Recommendation Status
Food and Drug Administration
Priority Rec.
This is a priority recommendation.
To help ensure the safety of food imported into the United States, the Commissioner of Food and Drugs should complete an analysis to determine the annual number of foreign food inspections that is sufficient to ensure comparable safety of imported and domestic food. If the inspection numbers from that evaluation are different from the inspection targets mandated in FSMA, FDA should report the results to Congress and recommend appropriate legislative changes.
Open

On March 25, 2020, GAO staff met with FDA officials to discuss the status of the recommendation. FDA officials said that they cannot meet the number of foreign inspections required under the FDA Food Safety Modernization Act (FSMA) due to capacity constraints, and FDA's current strategy for the safety of imported food relies on a "cumulative oversight" approach involving multiple programs (including the Third-Party Certification Program, the Foreign Supplier Verification Program, the Voluntary Qualified Importer Program, and systems recognition), in addition to foreign inspections. FDA

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For questions about a specific recommendation, contact the person or office listed with the recommendation. For general information about recommendations, contact GAO's Audit Policy and Quality Assurance office at (202) 512-6100 or apqa@gao.gov.