The Food and Drug Administration's Foreign For-Cause Drug Inspection Program Can Be Improved To Protect the Nation's Drug Supply

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Date Issued

Friday, June 24, 2022

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-01-19-01500

Report Type

Audit

Number of Recommendations

Questioned Costs

Funds for Better Use

Open Recommendations

This report has 6 open recommendations.

Recommendation Number	Significant Recommendation	Recommended Questioned Costs	Recommended Funds for Better Use
22-A-01-069.01	No	$0	$0
We recommend that the Food and Drug Administration identify and implement additional ways to improve the timeliness of its foreign for-cause drug inspection process
22-A-01-069.02	No	$0	$0
We recommend that the Food and Drug Administration consider streamlining the process for writing and reviewing EIRs to minimize potential delays due to unexpected events.
22-A-01-069.03	No	$0	$0
We recommend that the Food and Drug Administration conduct an analysis of the workloads of individuals responsible for: (1) determining final classification, (2) issuing warning letters, and (3) holding regulatory meetings, and address any potential issues identified by this analysis.
22-A-01-069.04	No	$0	$0
We recommend that the Food and Drug Administration implement policies and procedures to ensure that lead investigators assigned to inspections have completed the Level 1 Investigator Certification Process.
22-A-01-069.05	No	$0	$0
We recommend that the Food and Drug Administration ensure that supervisors review investigators' qualifications and document that they meet applicable training requirements when the investigator training records do not exist.
22-A-01-069.06	No	$0	$0
We recommend that the Food and Drug Administration review the training records of the lead investigators that were outside the scope of the audit to verify that documentation supports either: o that the investigators completed the required training courses, Level 1 Performance Audit, and Level 1 Investigator Certification, or o that investigators are recommended as "experienced investigators" by supervisors and have completed training courses equivalent to the current required training courses.