Spinalight, Inc. – FDA Inspection, Mar 19, 2015

Record Details

This FDA Inspection record concerns Spinalight, Inc., with an inspection on March 19, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: Spinalight, Inc.
Inspection Date: March 19, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 95daece1-69f4-49c8-ae67-d0fb0fa11c80

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 919385
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 820.181DMR - not or inadequately maintained
21 CFR 820.160(b)Distribution records
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
21 CFR 820.120Lack of or inadequate procedures for labeling
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.20(b)Lack of or inadequate organizational structure

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Other FDA inspections of Spinalight, Inc.

Date	Classification	Office	Project area
January 31, 2024	VAI	Center for Devices and Radiological Health	Compliance: Devices
July 19, 2012	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 18, 2011	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices