FDA Inspection 772394 — Hampton Medical Devices, LLC
The FDA completed an inspection of Hampton Medical Devices, LLC on Mar 15, 2012 in Festus, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 16 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 15, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Festus, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 17003 | FDCA 501(a) | Medical Device Field Exam |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3308 | 21 CFR 820.120(a) | Remain legible |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |