FDA Inspection 600960 — PMT Corporation
The FDA completed an inspection of PMT Corporation on Aug 4, 2009 in Chanhassen, MN. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 4, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chanhassen, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |