FDA Inspection 1067610 — Control Micro Systems, Inc.
The FDA completed an inspection of Control Micro Systems, Inc. on Sep 28, 2018 in Winter Park, FL. 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)
- End Date
- Sep 28, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Winter Park, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |
| 5173 | 21 CFR 1040.10(g)(5)(i) | Aperture label - laser radiation |
| 5814 | 21 CFR 1002.30(a)(2) | Basis for selecting methods, devices, procedures |