FDA Inspection 1335920 — Revolutionary Science
The FDA completed an inspection of Revolutionary Science on Sep 11, 2026 in Shafer, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Shafer, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23016 | ISO 13485:2016 Clause 4.1.1 | QMS not documented and maintained adequately |
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |