FDA Inspection
XTANT Medical Holdings, IncXTANT Medical Holdings, Inc – FDA Inspection, Jul 26, 2012
Record Details
This FDA Inspection record concerns XTANT Medical Holdings, Inc, with an inspection on July 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- XTANT Medical Holdings, Inc
- Inspection Date
- July 26, 2012
- Product Type
- Devices
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ID · 702b283d-6783-4eeb-a869-e1972b3a8260
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 793041
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 1271.195(b)Corrective actions
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.47(a)Procedures for all other requirements
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 1271.190(d)(1)Procedures for cleaning, sanitation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 1271.270(a)Records incomplete
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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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