FDA Inspection 946075 — Hampton Medical Devices, LLC
The FDA completed an inspection of Hampton Medical Devices, LLC on Aug 12, 2015 in Festus, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 12, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Festus, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3250 | 21 CFR 820.72(b)(2) | Calibration documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |