FDA Inspection 822164 — Medifix, Inc.
The FDA completed an inspection of Medifix, Inc. on March 18, 2013 in Morton Grove, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 18, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Morton Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3668 | 21 CFR 820.20(c) | Management review dates |