FDA Inspection
AEGIS Spine, Inc.AEGIS Spine, Inc. – FDA Inspection, Aug 30, 2013
Record Details
This FDA Inspection record concerns AEGIS Spine, Inc., with an inspection on August 30, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- AEGIS Spine, Inc.
- Inspection Date
- August 30, 2013
- Product Type
- Biologics
View Company Profile
ID · e7f1c1d0-8bc3-43be-8448-41203d09c6ba
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 847846
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.320(a)Procedures re complaints
Full citation text and observation details available on the Dashboard.
Other FDA inspections of AEGIS Spine, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 9, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 19, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for AEGIS Spine, Inc.
- FDA Inspection 1012457 - 2017-05-18
- FDA Inspection 1010585 - 2017-05-09
- FDA Inspection 871350 - 2014-03-19
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