FDA Inspection 1216784 — ARCADLAB, LLC
The FDA completed an inspection of ARCADLAB, LLC on September 1, 2023 in West Palm Beach, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 1, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- West Palm Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3668 | 21 CFR 820.20(c) | Management review dates |