FDA Inspection 1198080 — AADCO Medical Inc.
The FDA completed an inspection of AADCO Medical Inc. on Feb 22, 2023 in Randolph, VT. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Randolph, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |