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# Improve FDA Foreign For-Cause Inspections: OIG
- URL: https://www.fdaweb.com/improve-fda-foreign-for-cause-inspections-oig/
- Published: 2022-06-29T12:00:00.000Z
- Updated: 2026-09-14T17:50:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152198

The HHS Office of Inspector General (OIG) is recommending that FDA “identify and implement additional ways to improve the timeliness of its foreign for-cause drug inspection program.” In an [audit report](https://oig.hhs.gov/oas/reports/region1/11901500.pdf?ref=fdaweb.com), the OIG says its audit objective was to determine whether FDA’s foreign drug inspection process has improved since the agency made programmatic changes in 2017.

Specifically, the report says, the audit determined whether **(1)** timeframes for the foreign for-cause drug inspection process improved after FDA implemented the 2017 changes; **(2)** FDA’s foreign for-cause drug inspection process followed applicable policies and procedures; and **(3)** lead investigators conducting foreign for-cause drug inspections met FDA’s training requirements.

The OIG says FDA concurred with its recommendations for changes. “FDA stated that it is working to improve the timeliness of the overall foreign for-cause inspection process,” the report says. “Furthermore, pending approval by Congress, FDA stated that it has committed to goals regarding the timing of foreign facility follow-up inspections. FDA also stated that it is addressing ways to reduce the time spent writing and reviewing establishment inspection reports and that it is conducting a workload analysis for individuals responsible for determining final classification, issuing Warning Letters, and holding regulatory meetings. FDA stated that it will soon begin implementing a new system to better document and track investigators’ qualifications and certification.”