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Report File
Date Issued
Submitting OIG
Department of Health & Human Services OIG
Other Participating OIGs
Department of Health & Human Services OIG
Agencies Reviewed/Investigated
Department of Health & Human Services
Components
Food and Drug Administration
Report Number
A-01-16-01502
Report Description

Prior Office of Inspector General (OIG) reviews focused on U.S. Food and Drug Administration (FDA) oversight of food recalls. Food recalls are the most effective means of protecting public health when a widely consumed food product is either defective or potentially harmful. At the time of those OIG reviews, FDA did not have statutory authority to require food manufacturers to initiate recalls of most foods.

Report Type
Audit
Agency Wide
Yes
Number of Recommendations
14
Questioned Costs
$0
Funds for Better Use
$0
Additional Details
https://oig.hhs.gov/oas/reports/region1/11601502.asp

Open Recommendations

This report has 2 open recommendations.
Recommendation Number Significant Recommendation Recommended Questioned Costs Recommended Funds for Better Use Additional Details
261980 Yes $0 $0

FDA should 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

261973 No $0 $0

#4 - We recommend that FDA ensure, through its recall audit plan, that audit checks are issued at the level specified in the FDA audit program.

Department of Health & Human Services OIG

United States