Alphatec Spine, Inc. – FDA Inspection, May 18, 2009

Record Details

This FDA Inspection record concerns Alphatec Spine, Inc., with an inspection on May 18, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Alphatec Spine, Inc.
Inspection Date: May 18, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 84261187-ff87-4071-b935-e7aa8d844000

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 583462
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.100(a)(1)Analysis of data sources
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 806.10(b)Time to report - 10 days
21 CFR 820.40(a)Not approved or obsolete document retrieval
21 CFR 820.100(a)(3)Identification of actions needed
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.70(a)Process control procedures

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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