FDA Inspection 1017642 — Sunnex, LLC
The FDA completed an inspection of Sunnex, LLC on July 12, 2017 in Charlotte, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |