FDA Inspection 710362 — Medefil Incorporated
The FDA completed an inspection of Medefil Incorporated on Jan 31, 2011 in Glendale Heights, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 8 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 31, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Glendale Heights, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |