FDA Inspection 971370 — CURALLUX LLC
The FDA completed an inspection of CURALLUX LLC on May 10, 2016 in Doral, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 5031 | 21 CFR 1010.2(a) | Lack of certification of conformance |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |
| 5209 | 21 CFR 1040.11(a)(3) | Aperture label |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |