FDA Inspection 790810 — Medtronic Xomed, Inc.
The FDA completed an inspection of Medtronic Xomed, Inc. on Jul 3, 2012 in Mystic, CT. 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
- Jul 3, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mystic, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3837 | 21 CFR 820.25(b) | Training records |
| 796 | 21 CFR 803.55(a) | Initial Submission of Baseline Report |