Recommendations Tracker
HHS-OIG provides independent and objective oversight that promotes economy, efficiency, and effectiveness in HHS programs and operations. To drive this positive change, we produce reports and identify recommendations for improvement. We have developed this public-facing page for tracking all of our open recommendations.
Use the Top Unimplemented View below to read OIG's Top Unimplemented Recommendations. In OIG’s view, these top recommendations for HHS programs, if implemented, would have the greatest impact in terms of cost savings, program effectiveness and efficiency, and public health and safety. Learn more
Summary of All Recommendations
Updated Monthly · Last updated on April 15, 2026
1,094
Unimplemented
recommendations
3,367
Implemented and Closed
recommendations since FY 2017
Views
OIG Recommendations Grouped by Report
Showing 1,121–1,140 of 1,385 reports, containing 4,461 recommendations
Sorted by latest release date
-
Medicare Needs Better Controls To Prevent Fraud, Waste, and Abuse Related to Chiropractic Services
18-A-09-065.01We recommend that CMS work with its contractors to educate chiropractors on the training materials that are available to them.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2019
- Legislative Related
- No
18-A-09-065.02We recommend that CMS educate beneficiaries on the types of chiropractic services that are covered by Medicare, inform them that massage and acupuncture services are not covered by Medicare, and encourage them to report to CMS chiropractors who are providing non-Medicare-covered services.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 10/22/2018
- Legislative Related
- No
18-A-09-065.03We recommend that CMS identify chiropractors with aberrant billing patterns or high service-denial rates, select a statistically valid random sample of services provided by each chiropractor identified, review the medical records for the sampled services, estimate the amount overpaid to each chiropractor, and request that the chiropractors refund the amounts overpaid by Medicare.- Status
- Closed Unimplemented
- Responsible Agency
- CMS
- Response
- Non-Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 02/01/2019
- Legislative Related
- No
18-A-09-065.04We recommend that CMS establish a threshold for the number of chiropractic services beyond which medical review would be required for additional services.- Status
- Closed Unimplemented
- Responsible Agency
- CMS
- Response
- Non-Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 02/01/2019
- Legislative Related
- No
-
Arkansas Claimed Unallowable Federal Reimbursement for Some Medicaid Physician-Administered Drugs
18-A-06-063.01We recommend that the State agency refund to the Federal Government $8,516,758 (Federal share) for claims for single-source physician-administered drugs that were ineligible for Federal reimbursement.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Non-Concur
- Potential Savings
- $8,516,758
- Last Update Received
- -
- Closed Date
- 02/28/2018
- Legislative Related
- No
18-A-06-063.02We recommend that the State agency refund to the Federal Government $1,375,598 (Federal share) for claims for top-20 multiple-source physician-administered drugs that were ineligible for Federal reimbursement.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Non-Concur
- Potential Savings
- $1,375,598
- Last Update Received
- -
- Closed Date
- 02/28/2018
- Legislative Related
- No
18-A-06-063.03Work with CMS to determine the unallowable portion of $61,010 (Federal share) for other claims for covered outpatient physician-administered drugs that were submitted without NDCs or with invalid NDCs and that may have been ineligible for Federal reimbursement and refund that amount.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 02/28/2018
- Legislative Related
- No
18-A-06-063.04Work with CMS to determine whether the remaining $1,388,523 (Federal share) of other physician-administered drug claims could have been invoiced to the manufacturers to receive rebates and, if so, upon receipt of the rebates, refund the Federal share of the manufacturers' rebates for those claims.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 02/28/2018
- Legislative Related
- No
18-A-06-063.05We recommend that the State agency work with CMS to determine and refund the unallowable portion of Federal reimbursement for physician-administered drugs that were not invoiced for rebates after June 30, 2015.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 02/28/2018
- Legislative Related
- No
18-A-06-063.06We recommend that the State strengthen its internal controls to ensure that all physician-administered drugs eligible for rebates are invoiced.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 02/28/2018
- Legislative Related
- No
-
The Administration for Children and Families Region II Did Not Always Resolve Head Start Grantees' Single Audit Findings in Accordance With Federal Requirements
18-A-02-061.01We recommend that ACF review its staffing levels and determine whether resources are aligned efficiently, and adjust as needed, to ensure that the audit resolution process is conducted in accordance with Federal requirements, including the requirement to issue management decisions to grantees within 6 months- Status
- Closed Implemented
- Responsible Agency
- ACF
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 01/09/2019
- Legislative Related
- No
18-A-02-061.02We recommend that ACF provide training to Head Start grantees on implementing corrective action plans with sufficient information for ACF to determine whether corrective actions are adequate to resolve audit findings- Status
- Closed Implemented
- Responsible Agency
- ACF
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 01/09/2019
- Legislative Related
- No
18-A-02-061.03We recommend that ACF include in the letters sent to Head Start grantees specific dates for correcting deficiencies noted in the audit reports when corrective actions have not been completed.- Status
- Closed Unimplemented
- Responsible Agency
- ACF
- Response
- Non-Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 02/01/2019
- Legislative Related
- No
18-A-02-061.04We recommend that ACF strengthen its policies and procedures to include monitoring of Head Start grantees and conducting site visits, when feasible, to ensure that grantees implement appropriate corrective actions to resolve audit findings- Status
- Closed Unimplemented
- Responsible Agency
- ACF
- Response
- Non-Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 02/01/2019
- Legislative Related
- No
-
Henry J. Austin Health Center, Inc., a Health Resources and Services Administration Grantee, Did Not Comply With Federal Grant Requirements
18-A-02-062.01We recommend that HRSA require HJAHC to refund $8,000,453 to the Federal Government or work with HJAHC to determine what portion of these costs claimed to the Community Health Center Program grants were allowable.- Status
- Closed Implemented
- Responsible Agency
- HRSA
- Response
- Non-Concur
- Potential Savings
- $8,000,453
- Last Update Received
- -
- Closed Date
- 07/25/2018
- Legislative Related
- No
18-A-02-062.02We recommend that HRSA require HJAHC to refund $243,066 to the Federal Government.- Status
- Closed Implemented
- Responsible Agency
- HRSA
- Response
- Non-Concur
- Potential Savings
- $243,066
- Last Update Received
- -
- Closed Date
- 07/25/2018
- Legislative Related
- No
18-A-02-062.03We recommend that HRSA ensure that HJAHC develops and maintains a financial management system that provides for the accurate, current, and complete disclosure of the financial results of its Community Health Center Program grant funds, including (1) tracking and accounting for grant expenditures separately from other operating expenditures, (2) documenting a comparison of actual expenditures with budget amounts, and (3) maintaining records that support the distribution of employees' salaries and wages among specific activities and all expenditures charged to grant awards.- Status
- Closed Implemented
- Responsible Agency
- HRSA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 07/20/2018
- Legislative Related
- No
-
Palmetto Government Benefits Administrator, LLC, Claimed Some Unallowable Pension Costs Through Its Incurred Cost Proposals
18-A-07-060.01We recommend that Palmetto work with CMS to ensure that its final settlement of contract costs reflects a decrease in Medicare pension costs of $95,038 for CYs 2010 and 2011.- Status
- Closed Unimplemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $95,038
- Last Update Received
- -
- Closed Date
- 06/20/2018
- Legislative Related
- No
-
CGS Administrators, LLC, Did Not Claim Some Allowable Pension Costs Through Its Incurred Cost Proposals
18-A-07-059.01We recommend that CGS work with CMS to ensure that its final settlement of contract costs reflects an increase in Medicare pension costs of $12,475 for CY 2011.- Status
- Closed Unimplemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2018
- Legislative Related
- No
-
Medicare Compliance Review of the University of Michigan Health System
18-A-05-058.01We recommend that the Hospital refund to the Medicare contractor $6,162,201 (of which $1,294,130 was overpayments identified in our sample) in estimated net overpayments for incorrectly billed services.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Non-Concur
- Potential Savings
- $6,162,201
- Last Update Received
- -
- Closed Date
- 08/09/2018
- Legislative Related
- No
18-A-05-058.02We recommend that the Hospital exercise reasonable diligence to identify and return any additional similar overpayments received outside of our audit period, in accordance with the 60-day rule, and identify any returned overpayments as having been made in accordance with this recommendation.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $145,506
- Last Update Received
- -
- Closed Date
- 01/19/2023
- Legislative Related
- No
18-A-05-058.03We recommend that the Hospital strengthen controls to ensure full compliance with Medicare requirements.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/09/2018
- Legislative Related
- No
-
Medicare Advantage Encounter Data Show Promise for Program Oversight, But Improvements Are Needed
18-E-03-008.01CMS should take actions as appropriate to address potential errors in the MA encounter data.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 11/08/2018
- Legislative Related
- No
18-E-03-008.02CMS should provide targeted oversight of Medicare Advantage Organizations (MAOs) that submitted a higher percentage of encounter records with potential errors.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 05/02/2022
- Legislative Related
- No
18-E-03-008.03CMS should ensure that billing provider identifiers are valid and active on all records in the MA encounter data.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 01/21/2020
- Legislative Related
- No
18-E-03-008.04CMS should require MAOs to submit ordering and referring provider identifiers for applicable records.- Status
- Closed Unimplemented
- Responsible Agency
- CMS
- Response
- Non-Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 01/21/2020
- Legislative Related
- No
18-E-03-008.05CMS should ensure that MAOs submit rendering provider identifiers for applicable records.- Status
- Open Unimplemented
- Responsible Agency
- CMS
- Response
- Non-Concur
- Potential Savings
- -
- Last Update Received
- 05/23/2024
- Next Update Expected
- 06/11/2025
- Legislative Related
- No
18-E-03-008.06CMS should track MAOs' response to reject edits.- Status
- Closed Unimplemented
- Responsible Agency
- CMS
- Response
- Non-Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 04/10/2024
- Legislative Related
- No
18-E-03-008.07CMS should establish and monitor Medicare Advantage encounter data performance thresholds related to MAO's submission of records with complete and valid data.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 05/02/2022
- Legislative Related
- No
-
Medicare Compliance Review of Carolinas Medical Center
18-A-04-052.01We recommended that the hospital refund to the Medicare program $1,659,619 in estimated overpayments for the audit period for claims that it incorrectly billed.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $1,659,619
- Last Update Received
- -
- Closed Date
- 06/19/2018
- Legislative Related
- No
18-A-04-052.02We recommended that the hospital exercise reasonable diligence to identify and return any additional similar overpayments received outside of our audit period, in accordance with the 60-day rule, and identify any returned overpayments as having been made in accordance with this recommendation.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $48,513
- Last Update Received
- -
- Closed Date
- 02/08/2022
- Legislative Related
- No
18-A-04-052.03We recommended that the hospital strengthen controls to ensure full compliance with Medicare requirements.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 02/08/2018
- Legislative Related
- No
-
New York Did Not Correctly Determine Medicaid Eligibility for Some Newly Enrolled Beneficiaries
18-A-02-049.01We recommend that the State agency redetermine, as appropriate, the current Medicaid eligibility status of the sample beneficiaries who did not meet Federal and State eligibility requirements.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 05/31/2018
- Legislative Related
- No
18-A-02-049.02We recommend that the State agency improve the design of its enrollment system to ensure that it maintains applications, verifies income and citizenship eligibility data, and determines eligibility by using available electronic data sources, as appropriate.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 05/31/2018
- Legislative Related
- No
-
Wisconsin Physicians Service Insurance Corporation Did Not Claim Some Allowable Medicare Pension Costs
18-A-07-050.01We recommend that WPS revise its FACPs for FYs 2008 through 2013 to claim additional Medicare pension costs of $1,006,229.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/20/2018
- Legislative Related
- No
-
Wisconsin Physicians Service Insurance Corporation Understated Its Allocable Pension Costs
18-A-07-051.01We recommend that WPS increase the Medicare segment pension costs used to calculate its indirect cost rates by $1,538,916 for CYs 2008 through 2013.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 03/03/2022
- Legislative Related
- No
18-A-07-051.02We recommend that WPS increase the Other segment pension costs used to calculate its indirect cost rates by $7,155,498 for CYs 2008 through 2013.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 03/03/2022
- Legislative Related
- No
-
North Carolina Did Not Always Verify Correction of Deficiencies Identified During Surveys of Nursing Homes Participating in Medicare and Medicaid
18-A-04-045.01We recommend that the State survey agency provide guidance and training to its surveyors to ensure that they properly upload system data.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2018
- Legislative Related
- No
18-A-04-045.02We recommend that the State survey agency ensure that it obtains, reviews, and verifies adequate documentation that supports all aspects of nursing home correction plans.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2018
- Legislative Related
- No
-
Wisconsin Physicians Service Insurance Corporation Understated Its Medicare Segment Pension Assets for Its Employees' Pension Plan
18-A-07-046.01We recommend that WPS increase the Medicare segment pension assets by $241,574 and recognize $16,325,616 as the Medicare segment pension assets as of December 31, 2012.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $241,574
- Last Update Received
- -
- Closed Date
- 01/18/2018
- Legislative Related
- No
18-A-07-046.02We recommend that WPS implement controls, including policies and procedures, to ensure compliance with Federal regulations and the pension segmentation language of the Medicare contracts.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 01/18/2018
- Legislative Related
- No
-
Wisconsin Physicians Service Insurance Corporation Understated Its Medicare Segment Pension Assets for Its Managerial Retirement Program for Selected Locations
18-A-07-047.01We recommend that WPS increase the Medicare segment pension assets by $33,463 and recognize $24,857,342 as the Medicare segment pension assets as of December 31, 2009.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $33,463
- Last Update Received
- -
- Closed Date
- 01/18/2018
- Legislative Related
- No
18-A-07-047.02We recommend that WPS implement controls, including policies and procedures, to ensure compliance with Federal regulations and the pension segmentation language of the Medicare contracts.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 01/18/2018
- Legislative Related
- No
-
Wisconsin Physicians Service Insurance Corporation Understated Its Medicare Segment Pension Assets for Its Managerial Pension Plan
18-A-07-048.01We recommend that WPS increase the Medicare segment pension assets by $3,214,152 and recognize $68,813,688 as the Medicare segment pension assets as of December 31, 2013.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $3,214,152
- Last Update Received
- -
- Closed Date
- 01/18/2018
- Legislative Related
- No
18-A-07-048.02We recommend that WPS implement controls, including policies and procedures, to ensure compliance with Federal regulations and the pension segmentation language of the Medicare contracts.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 01/18/2018
- Legislative Related
- No
-
Texas Did Not Always Calculate Physician Supplemental Payments Made to the Texas Tech University Health Institutions in Accordance With Federal and State Requirements
18-A-06-043.01We recommend that the State agency refund to the Federal Government the $9,911,321 Federal share of improper supplemental payments made to the TTU health institutions.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $9,911,321
- Last Update Received
- -
- Closed Date
- 09/28/2018
- Legislative Related
- No
-
Texas Did Not Appropriately Spend Some State Balancing Incentive Payments Program Funds
18-A-06-042.01We recommend that the State agency refund $11,982,826 in BIPP funds.- Status
- Closed Unimplemented
- Responsible Agency
- CMS
- Response
- Non-Concur
- Potential Savings
- $11,982,826
- Last Update Received
- -
- Closed Date
- 03/31/2020
- Legislative Related
- No
18-A-06-042.02We recommend that the State agency separately track funds for any future grant programs to ensure that the funds are not used in violation of applicable statutory restrictions or prohibitions.- Status
- Closed Unimplemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 03/28/2019
- Legislative Related
- No
18-A-06-042.03We recommend that the State agency ensure that all grant procedures and requirements for future grant programs are met, including following instructions for extending funding periods.- Status
- Closed Unimplemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 05/02/2019
- Legislative Related
- No
-
Georgia Made Unallowable Capitation Payments for Beneficiaries Assigned Multiple Medicaid Identification Numbers
18-A-04-041.01We recommend that the State agency refund to the Federal Government $540,984 (Federal share) in overpayments that fell within our audit period.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $540,984
- Last Update Received
- -
- Closed Date
- 06/07/2018
- Legislative Related
- No
18-A-04-041.02We recommend that the State agency refund to the Federal Government $126,488 (Federal share) in overpayments that fell outside of our audit period.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- $126,488
- Last Update Received
- -
- Closed Date
- 06/07/2018
- Legislative Related
- No
18-A-04-041.03We recommend that the State agency enhance or establish new controls to ensure that no beneficiary is issued multiple Medicaid ID numbers.- Status
- Closed Implemented
- Responsible Agency
- CMS
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 06/07/2018
- Legislative Related
- No
-
The Food and Drug Administration's Food-Recall Process Did Not Always Ensure the Safety of the Nation's Food Supply
18-A-01-040.01We recommend that FDA establish set timeframes, through its SCORE initiative, for (1) FDA to discuss the possibility of a voluntary recall with a firm and (2) FDA to initiate use of its mandatory recall authority after it has made the determination that the legal standard for use of that authority has been met and a firm is not willing to voluntarily conduct a recall.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2019
- Legislative Related
- No
18-A-01-040.02We recommend that FDA include in its recall audit plan a step to monitor when the recall alert was submitted to the RES in accordance with current FDA alert submission procedures and, if appropriate, take steps to encourage the recall staff's submission of the recall audit plan to the RES as soon as possible and preferably within 24 hours after learning of a firm-initiated recall.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2019
- Legislative Related
- No
18-A-01-040.03We recommend that FDA finalize its interim mandatory recall procedures and consider issuing guidance for FDA staff on those factors that staff should consider when determining whether there is a reasonable probability that a food could cause serious adverse health consequence or death.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2019
- Legislative Related
- No
18-A-01-040.04We recommend that FDA ensure, through its recall audit plan, that audit checks are issued at the level specified in the FDA audit program.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 11/03/2021
- Legislative Related
- No
18-A-01-040.05We recommend that FDA develop procedures to determine whether a reconciliation of distribution lists to shipping records is necessary to ensure that FDA uses complete and accurate distribution lists when assigning audit checks.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 03/03/2020
- Legislative Related
- No
18-A-01-040.06We recommend that FDA increase the use of third-party audit checks through its recall strategic plan.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 03/03/2020
- Legislative Related
- No
18-A-01-040.07We recommend that FDA ensure, through its recall audit plan, that FDA district offices conducting audit checks follow procedures by completing audit check status updates and providing audit check reports, as directed by the recall coordinators.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2019
- Legislative Related
- No
18-A-01-040.08We recommend that FDA improve audit check tracking and monitoring using the RES or another FDA system.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2019
- Legislative Related
- No
18-A-01-040.09We recommend that FDA implement procedures to request status reports at the initiation of the recall and, through its recall audit plan, ensure FDA monitoring district offices follow up with firms that do not provide timely or complete status reports.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 07/06/2020
- Legislative Related
- No
18-A-01-040.10We recommend that FDA develop a policy for defining and a procedure for identifying retrospectively the date that FDA learns of a potentially hazardous product and consider adding a field for the date to the RES or another FDA system so that FDA staff involved in managing a recall have access to this information.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 11/03/2021
- Legislative Related
- No
18-A-01-040.11We recommend that FDA establish performance measures for the amount of time between the date FDA learns of a potentially hazardous product and the date a firm initiates a voluntary recall, monitor performance, and refine operating procedures, as needed.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 05/27/2022
- Legislative Related
- No
18-A-01-040.12We recommend that FDA clarify the definition of “recall initiation date” in its policies and procedures and ensure a consistent understanding of “recall initiation date” among recall personnel.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2019
- Legislative Related
- No
18-A-01-040.13We recommend that FDA develop and implement a data quality assurance process, through its recall audit plan, to ensure that the RES contains accurate information.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2019
- Legislative Related
- No
18-A-01-040.14We recommend that FDA consider the results of our review when implementing its recent SCORE initiative.- Status
- Closed Implemented
- Responsible Agency
- FDA
- Response
- Concur
- Potential Savings
- -
- Last Update Received
- -
- Closed Date
- 08/08/2019
- Legislative Related
- No