Restor3D, Inc. — FDA Facility Profile
Restor3D, Inc. is an FDA-registered facility (FEI 3014833750) located in Durham, NC, US. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jun 14, 2024: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (2 VAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jun 14, 2024 | Voluntary Action Indicated (VAI) | DHR - not or inadequately maintained (21 CFR 820.184) Design verification - output does not meet input requirement (21 CFR 820.30(f)) Labeling inspection - UDI (21 CFR 820.120(b)) Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a)) and 3 more |
| May 12, 2023 | Voluntary Action Indicated (VAI) | Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Lack of or inadequate procedures (21 CFR 820.100(a)) Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50) |
Facility details
- Company
- Restor3D Inc.
- Location
- Durham, NC (US)
- Source
- device