FDA Inspection 561904 — IZI Medical Products, LLC
The FDA completed an inspection of IZI Medical Products, LLC on Mar 3, 2009 in Owings Mills, MD. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 3, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Owings Mills, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2627 | 21 CFR 820.30(e) | Design reviews performed following schedule |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |