FDA Inspection
Alphatec Spine, Inc.Alphatec Spine, Inc. – FDA Inspection, Feb 11, 2010
Record Details
This FDA Inspection record concerns Alphatec Spine, Inc., with an inspection on February 11, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alphatec Spine, Inc.
- Inspection Date
- February 11, 2010
- Product Type
- Devices
View Company Profile
ID · d813161d-4f49-48cf-abc9-e09fa625b70f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 645528
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 803.52(f)(1)Type of Reportable Event
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.30(d)Essential design outputs
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.90(a)Nonconforming product control
Showing 10 of 11 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Alphatec Spine, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 19, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 13, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 27, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Alphatec Spine, Inc.
- FDA Inspection 1175442 - 2022-07-18
- FDA Inspection 1020129 - 2017-04-19
- FDA Inspection 917997 - 2015-03-13
- FDA Inspection 836180 - 2013-06-14
- FDA Inspection 779000 - 2012-04-27
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.