Alphatec Spine, Inc. – FDA Inspection, Dec 13, 2010

Record Details

This FDA Inspection record concerns Alphatec Spine, Inc., with an inspection on December 13, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Alphatec Spine, Inc.
Inspection Date: December 13, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 995899be-b25e-49fc-9b13-076fb61391d1

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 705415
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 803.56Submission of Supplement to Individual Report Within One Month
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.25(b)Training records
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.70(a)Production processes

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Other FDA inspections of Alphatec Spine, Inc.

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