FDA Inspection 1181370 — CK Warmy LLC.
The FDA completed an inspection of CK Warmy LLC. on Oct 11, 2022 in Miami, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 11, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5042 | 21 CFR 1010.3(a) | ID label or tag |
| 5168 | 21 CFR 1040.10(g)(2)(i) | Class IIIa "Caution" label |
| 5173 | 21 CFR 1040.10(g)(5)(i) | Aperture label - laser radiation |
| 5211 | 21 CFR 1040.11(b) | Surveying, leveling, alignment laser products |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |