FDA Inspection 645512 — Zefon International
The FDA completed an inspection of Zefon International on Feb 11, 2010 in Ocala, FL. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 11, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ocala, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |