FDA Inspection 831607 — PMT Corporation
The FDA completed an inspection of PMT Corporation on Jun 6, 2013 in Chanhassen, MN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 6, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chanhassen, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 4208 | 21 CFR 806.20(a) | Records not kept |
| 537 | 21 CFR 820.70(a) | Production processes |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |