FDA Inspection 808935 — Medefil Incorporated
The FDA completed an inspection of Medefil Incorporated on Dec 20, 2012 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glendale Heights, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |