FDA Inspection
XTANT Medical Holdings, IncXTANT Medical Holdings, Inc – FDA Inspection, Aug 2, 2013
Record Details
This FDA Inspection record concerns XTANT Medical Holdings, Inc, with an inspection on August 2, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- XTANT Medical Holdings, Inc
- Inspection Date
- August 2, 2013
- Product Type
- Biologics
View Company Profile
ID · a412bab8-4ef9-4692-8975-ac487b62df05
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 843894
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
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
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.