FDA Inspection 701184 — UROMATRIX Medical Systems (A Pos-T-Vac Medical Company)
The FDA completed an inspection of UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) on December 2, 2010 in Martinez, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 2, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Martinez, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4430 | 21 CFR 803.18(d)(1) | Distributor responsibilities for complaint records |
| 4431 | 21 CFR 803.18(d)(1) | Distributor's device incident records |