Penalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation · 333(f)(4)(A)(ii)

For Penalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation, statutory authority is 333(f)(4)(A)(ii); agency is HHS; maximum penalty is 377,701, recorded from its source on 2026-08-10.

Values marked our reading are our classification of what the source says — the source does not print them in those words. The quote below is the evidence for each one; judge it yourself.

What the source says

333(f)(4)(A)(ii) | | FDA | Penalty for REMS violation that continues after written notice to the responsible person for the first 30-day period (or any portion thereof) the responsible person continues to be in violation | 2024 | 368,137 | 377,701

— ecfr.gov, retrieved 2026-08-10

Source

• ecfr.govhttps://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-102/section-102.3

Last verified against source: 2026-08-10. Due for re-check by 2027-02-26. This page as Markdown · OKF bundle · full dataset as JSON.