FDA Inspection 1066862 — GAM Laser, Inc.
The FDA completed an inspection of GAM Laser, Inc. on Sep 25, 2018 in Orlando, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 25, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5197 | 21 CFR 1040.10(h)(1)(i) | User information, adequate instructions |
| 5198 | 21 CFR 1040.10(h)(1)(ii) | User information, radiation output information |
| 5200 | 21 CFR 1040.10(h)(1)(iv) | User info - list controls, etc. |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |
| 5813 | 21 CFR 1002.30(a)(2) | Methods, devices, procedures for testing |