Atlas Spine, Inc. – FDA Inspection, Mar 4, 2011

Record Details

This FDA Inspection record concerns Atlas Spine, Inc., with an inspection on March 4, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Atlas Spine, Inc.
Inspection Date: March 4, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · cc86cad0-9ff3-4cf0-92b9-d0221984b68d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 713125
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(c)Design input - Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.198(e)Records of complaint investigation
21 CFR 820.30(g)Design validation - Risk analysis
21 CFR 820.30(f)Design verification - documentation
21 CFR 820.30(g)Design validation - documentation

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Other FDA inspections of Atlas Spine, Inc.

Date	Classification	Office	Project area
May 27, 2025	VAI	Florida District Office	Compliance: Medical Devices
December 6, 2022	NAI	Center for Devices and Radiological Health	Compliance: Devices
July 19, 2019	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 26, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices
March 7, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices