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# FDA Touts Alternative Inspection Oversight Results
- URL: https://www.fdaweb.com/fda-touts-alternative-inspection-oversight-results/
- Published: 2021-03-18T12:00:00.000Z
- Updated: 2026-09-14T16:51:21.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5148919

FDA acting commissioner **Janet Woodcock** and associate commissioner for regulatory affairs **Janet McMeekin** say the agency has used alternative oversight tools when the pandemic prevented investigators from entering facilities for inspections. Writing in an *FDA Voice* [post](https://www.fda.gov/news-events/fda-voices/fdas-ongoing-use-inspectional-tools-ensuring-access-safe-quality-food-and-medical-products-during?ref=fdaweb.com), the two say the agency prioritized “mission-critical” inspections on a case-by-case basis. When an in-person inspection was not possible, they say, FDA used: 

- compliance history reviews of facilities, including recalls and product complaints, to assist with prioritization;
- leveraging information shared by trusted state, local, and foreign regulatory partners through mutual recognition and confidentiality agreements;
- remote assessments for individual program areas to evaluate facility records;
- review of records and information requests to facilities in advance or instead of drug and biological product inspections, and/or to support regulatory decisions and actions;
- sampling and analytical testing of FDA-regulated products domestically and at the border; and
- refusing entry of unsafe products into the U.S.

Woodcock and McMeekin say FDA continues to assess its efforts to execute regulatory oversight. Some of the results highlights they cite are: 

- taking on-time actions to evaluate and close-out new and generic drug applications more than 90% of the time, meeting review program performance commitments;
- refusing more than $1.2 million worth of filtering faceplate respirators to prevent the proliferation of ineffective respirators used by healthcare workers;
- placing dangerous and sub potent hand sanitizers on import alert;
- · conducting a mix of mission-critical onsite inspections and remote record reviews to help ensure product approvals/authorizations were not delayed;
- using several tools to ensure that medical devices continue to meet requirements for safety and effectiveness.