FDA Inspection 1152925 — Inova Lasers LLC
The FDA completed an inspection of Inova Lasers LLC on September 17, 2021 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 17, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5199 | 21 CFR 1040.10(h)(1)(iii) | Legible reproductions |
| 5209 | 21 CFR 1040.11(a)(3) | Aperture label |
| 5784 | 21 CFR 1010.2(b) | Certification other than by tag or label |