FDA Inspection 992243 — Elite Spine LLC
The FDA completed an inspection of Elite Spine LLC on November 16, 2016 in Collegeville, PA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 16, 2016
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Collegeville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |