FDA Inspection 1221606 — VapoCoolShot, Inc.
The FDA completed an inspection of VapoCoolShot, Inc. on Oct 26, 2023 in Boca Raton, 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 26, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |