Company
United StatesAlphatec Spine, Inc., Carlsbad, CA – FDA Inspections
Inspection records and compliance data for Alphatec Spine, Inc. in Carlsbad, California. 8 FDA inspections on record (3 OAI), 1 Form 483, 1 warning letter, last inspected July 18, 2022.
Company Profile
This profile covers Alphatec Spine, Inc. based in Carlsbad, California, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 3
- VAI
- 2
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 1
First inspected May 18, 2009. Last inspected July 18, 2022.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Lack of or inadequate process validation3 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ2 inspections
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 18, 2022 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 1175442 |
| April 19, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1020129 |
| March 13, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 917997 |
| June 14, 2013 | NAI | Biologics, Medical Devices & Rad Health · Human Cellular, Tissue, and Gene Therapies | 836180 |
| April 27, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 779000 |
| December 13, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 705415 |
| February 11, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 645528 |
| May 18, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 583462 |
FDA documents
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Alphatec Spine, Inc.
FEI Number
2027467
Address
1950 Camino Vida Roble, Carlsbad, California 92008, United States
Country
United States
ID: ed7e822c-390b-4aa0-b01d-6455663bbe71