FDA Inspection 1209270 — Advance Medical Designs, Inc.
The FDA completed an inspection of Advance Medical Designs, Inc. on Jun 30, 2023 in Marietta, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 30, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Marietta, GA (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 |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |