FDA Inspection 1181370 — CK Warmy LLC. dba WarForce USA
The FDA completed an inspection of CK Warmy LLC. dba WarForce USA on October 11, 2022 in Miami, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 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 |