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# 8 Inspection Takeaways from New FDA Law
- URL: https://www.fdaweb.com/8-inspection-takeaways-from-new-fda-law/
- Published: 2023-02-07T12:00:00.000Z
- Updated: 2026-09-14T18:15:00.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153719

Two former FDAers, now working with Greenleaf Health, list eight key takeaways from the new Food and Drug Omnibus Reform Act that was signed into law on 12/29/22\. The article was written by **Donald Ashley**, who was FDA Office of Compliance director for six years, and **Kalah Auchincloss**, whose six years at FDA were in the Commissioner’s Office and in CDER’s Office of Compliance and Office of Regulatory Policy.

Writing in *Cell &* Gene they list the [takeaways](https://www.cellandgene.com/doc/the-key-takeaways-for-fda-inspections-in-the-food-and-drug-omnibus-reform-act-0001?ref=fdaweb.com) as:

- expanding the availability of alternative tools to inspection;
- clarifying the statutory basis for bioresearch monitoring inspections;
- recognition of foreign government inspections;
- regional compliance history added as a surveillance inspection criterion;
- GAO directed to prepare a report on alternative tools used by FDA and foreign counterparts;
- expect more unannounced foreign inspections;
- previously sunset provisions to prevent shortages in enforcement cases are revitalized; and
- annual report on inspections.