FDA Inspection 1191631 — Rebuilder Medical, Inc.
The FDA completed an inspection of Rebuilder Medical, Inc. on November 29, 2022 in Charles Town, WV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 29, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charles Town, WV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |