FDA Inspection 562313 — Medefil Incorporated
The FDA completed an inspection of Medefil Incorporated on Feb 19, 2009 in Glendale Heights, IL. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Glendale Heights, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |