FDA Inspection 844585 — IZI Medical Products, LLC
The FDA completed an inspection of IZI Medical Products, LLC on Jul 31, 2013 in Owings Mills, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 31, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Owings Mills, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |