Captiva Spine, Inc – FDA Inspection, Mar 9, 2012

Record Details

This FDA Inspection record concerns Captiva Spine, Inc, with an inspection on March 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Captiva Spine, Inc
Inspection Date: March 9, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 892736c3-1d86-44ce-b26a-40054ef40f31

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 771991
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 806.20(b)(4)Justification for not reporting
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.30(c)Design input - documentation
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.75(a)Documentation

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Other FDA inspections of Captiva Spine, Inc

Date	Classification	Office	Project area
February 13, 2025	Not classified	Florida District Office
January 14, 2025	NAI	Center for Devices and Radiological Health	Compliance: Devices
May 14, 2019	NAI	Center for Biologics Evaluation and Research	Human Cellular, Tissue, and Gene Therapies
February 17, 2017	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
January 16, 2013	VAI	Center for Devices and Radiological Health	Compliance: Devices