FDA Inspection 883715 — Stradis Medical, LLC dba Stradis Healthcare
The FDA completed an inspection of Stradis Medical, LLC dba Stradis Healthcare on March 26, 2014 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Peachtree Corners, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |