14. Department of Health and Human Services · Notable
Replace pass/fail drug facility inspections with a graded system
Printed page 457 14. Department of Health and Human Services
“The FDA should expand its current pass/fail approach to drug facility inspections into a graded system that recognizes manufacturers that exceed minimum standards by investing in improving production reliability.”
What has happened
- Not started
FDA's drug facility inspection system is still pass/fail. The graded alternative - the Quality Management Maturity program - exists only as a voluntary prototype assessment run under docket FDA-2023-N-5706, which opened before the window; FDA announced its second year on 2025-04-23 and its third on 2026-02-11, still describing it as a prototype whose purpose is to "gain additional experience with the assessment tool and process." No rating is published, nothing turns on the score, and no rule or guidance replaces the inspection classification system.
Research log
What was searched, and what didn’t count as evidence
Research notes
- Full-text Federal Register search for “graded system” since 2025-01-20 returns 0 documents.
- Boundary call: continuing and refining an inherited pilot for two more years could be read as attempted. It is held at not started because the program is pre-window, voluntary and has not changed how any inspection is classified.
- Action
- expand
- Object
- FDA drug facility inspection system
- ID
- 1229