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
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, agency is HHS; statutory authority is 333(f)(4)(A)(ii); maximum penalty is 377,701, recorded from its source on 2026-08-10.
- Agency
- HHS our reading
- Violation
- 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 verified
- Statutory authority
- 333(f)(4)(A)(ii) verified
- Maximum penalty
- 377,701 verified
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