FDA Inspection 1241159 — restor3d Inc.
The FDA completed an inspection of restor3d Inc. on June 14, 2024 in Durham, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 14, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Durham, NC (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |