FDA Inspection 643589 — Z-Medica, LLC
The FDA completed an inspection of Z-Medica, LLC on February 2, 2010 in Wallingford, CT. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 2, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Wallingford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3696 | 21 CFR 820.100(b) | Documentation |