FDA Inspection 1216784 — ARCADLAB, LLC
The FDA completed an inspection of ARCADLAB, LLC on Sep 1, 2023 in West Palm Beach, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 1, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: 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 |