FDA Inspection 678198 — Medtronic Xomed, Inc.
The FDA completed an inspection of Medtronic Xomed, Inc. on Aug 5, 2010 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mystic, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |