FDA Inspection 1229859 — Profusa Products Inc
The FDA completed an inspection of Profusa Products Inc on Feb 14, 2024 in South Miami, FL. 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). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 14, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- South Miami, FL (United States)
Additional Details
FSVP
Citations
| ID | CFR | Description |
|---|---|---|
| 18281 | 21 CFR 1.505(a)(2) | Evaluation - performance, risk |
| 18295 | 21 CFR 1.506(d)(1)(i) | Verification activity assurance |
| 18303 | 21 CFR 1.506(e)(1) | Verification activity before import, periodically |