FDA Inspection 844630 — Barnett International Corporation
The FDA completed an inspection of Barnett International Corporation on August 23, 2013 in Stallings, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Stallings, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |