FDA Inspection 1084279 — Nutraluxe Global, LLC #1
The FDA completed an inspection of Nutraluxe Global, LLC #1 on March 15, 2019 in Fort Myers, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 15, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fort Myers, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |