FDA Inspection 566047 — Avalign Integrated Medical Solutions, Inc.
The FDA completed an inspection of Avalign Integrated Medical Solutions, Inc. on Mar 2, 2009 in Mentor, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 2, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Mentor, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3291 | 21 CFR 820.100(b) | Procedures |