FDA Inspection 983042 — Monteris Medical Corp
The FDA completed an inspection of Monteris Medical Corp on Jun 30, 2016 in Minnetonka, 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 30, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Minnetonka, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |