FDA Inspection 732286 — Southern Spine, LLC
The FDA completed an inspection of Southern Spine, LLC on March 24, 2011 in Macon, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Macon, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17003 | FDCA 501(a) | Medical Device Field Exam |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |