The Food and Drug Administration's Food-Recall Process Did Not Always Ensure the Safety of the Nation's Food Supply

Submitting OIG:

Department of Health & Human Services OIG

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.

Date Issued:

Friday, December 22, 2017

Agency Reviewed / Investigated:

Department of Health & Human Services

Submitting OIG-Specific Report Number:

A-01-16-01502

Component, if applicable:

Food and Drug Administration

Location(s):

Agency-Wide

Type of Report:

Audit

Questioned Costs:

Funds for Better Use:

Number of Recommendations:

View Document:

Attachment	Size
11601502.pdf	4.83 MB

Additional Details Link:

https://oig.hhs.gov/oas/reports/region1/11601502.asp

Related Open Recommendations

Recommendation Number	Recommendation Status	Significant Recommendation
261973	Open	No
#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.
261980	Open	Yes
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

Recommendation Number

Recommendation Status

Significant Recommendation

Additional Details

261973

Open

#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.

261980

Open

Yes

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

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The Food and Drug Administration's Food-Recall Process Did Not Always Ensure the Safety of the Nation's Food Supply

Related Open Recommendations