Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period
For Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period, agency is HHS; maximum penalty is 1,510,803, recorded from its source on 2026-08-10.
- Agency
- HHS our reading
- Violation
- Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period verified
- Maximum penalty
- 1,510,803 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
| | FDA | Penalty for REMS violation that continues after written notice to responsible person doubles for every 30-day period thereafter the violation continues, but may not exceed penalty amount for any 30-day period | 2024 | 1,472,546 | 1,510,803
— ecfr.gov, retrieved 2026-08-10
Source
- ecfr.govhttps://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-102/section-102.3