FDA Inspection 729891 — 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 June 8, 2011 in Martinez, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 8, 2011
- 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 |