FDA Inspection 593499 — Stradis Medical, LLC dba Stradis Healthcare
The FDA completed an inspection of Stradis Medical, LLC dba Stradis Healthcare on April 3, 2009 in Peachtree Corners, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 3, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Peachtree Corners, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4189 | 21 CFR 820.198(a) | General |