FDA Inspection 1196089 — Avotec, Inc.
The FDA completed an inspection of Avotec, Inc. on Jan 27, 2023 in Stuart, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 27, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Stuart, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |