FDA Inspection 626767 — Medtronic Monitoring Inc.
The FDA completed an inspection of Medtronic Monitoring Inc. on Oct 23, 2009 in Saint Paul, 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). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 23, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Paul, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3675 | 21 CFR 820.30(f) | Design verification - unresolved discrepancies |
| 3693 | 21 CFR 820.100(a)(5) | Implementing changes |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |