FDA Inspection 847846 — AEGIS Spine, Inc.
The FDA completed an inspection of AEGIS Spine, Inc. on Aug 30, 2013 in Costa Mesa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 30, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Costa Mesa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |