FDA Inspection 929386 — IZI Medical Products, LLC
The FDA completed an inspection of IZI Medical Products, LLC on Jun 4, 2015 in Owings Mills, MD. 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
- Jun 4, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Owings Mills, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |