FDA Inspection
XTANT Medical Holdings, IncXTANT Medical Holdings, Inc – FDA Inspection, Aug 10, 2011
Record Details
This FDA Inspection record concerns XTANT Medical Holdings, Inc, with an inspection on August 10, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- XTANT Medical Holdings, Inc
- Inspection Date
- August 10, 2011
- Product Type
- Biologics
View Company Profile
ID · 8fc32cec-faf0-4c91-b9c1-18fefad830ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 745194
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of XTANT Medical Holdings, Inc
13| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 21, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 18, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 1, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for XTANT Medical Holdings, Inc
- FDA Inspection 1149034 - 2021-08-13
- FDA Inspection 1026635 - 2017-08-25
- FDA Inspection 1024416 - 2017-08-21
- FDA Inspection 969771 - 2016-05-18
- FDA Inspection 876734 - 2014-05-01
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