FDA Inspection 604183 — Rebuilder Medical, Inc.
The FDA completed an inspection of Rebuilder Medical, Inc. on August 17, 2009 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charles Town, WV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3156 | 21 CFR 820.181(b) | DMR production process specifications |
| 3167 | 21 CFR 820.198(a) | Complete files maintained |
| 3398 | 21 CFR 820.80(d)(3) | No release signature |
| 4189 | 21 CFR 820.198(a) | General |