# 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 — Federal civil penalty maximums — current inflation-adjusted amounts across agencies

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, not quoted from the source)_
- **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: appears in the quote below)_
- **Statutory authority:** 333(f)(4)(A)(ii) _(verified: appears in the quote below)_
- **Maximum penalty:** 377,701 _(verified: appears in the quote below)_

## 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

## Source

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

Last verified: 2026-08-10. Review by: 2027-02-26.
Part of [Federal civil penalty maximums — current inflation-adjusted amounts across agencies](https://referencesource.org/federal-civil-penalty-maximums/).