FDA Inspection 1098383 — CROSSROADS EXTREMITY SYSTEMS LLC
The FDA completed an inspection of CROSSROADS EXTREMITY SYSTEMS LLC on August 2, 2019 in Memphis, TN. 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 2, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Memphis, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |