BURTON MEDICAL – FDA Inspection, Feb 27, 2013

Record Details

This FDA Inspection record concerns BURTON MEDICAL, with an inspection on February 27, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company: BURTON MEDICAL
Inspection Date: February 27, 2013
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 2a97648f-3bcd-4887-bcd2-1b6f30ea4af7

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 822959
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.20(d)Quality plan
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
21 CFR 820.40(a)Document review, approval by designated individual
21 CFR 820.25(a)Personnel
21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
21 CFR 820.22Quality audit - audit report review
21 CFR 820.200(b)Analyzing service report

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Other FDA inspections of BURTON MEDICAL

Date	Classification	Office	Project area
February 20, 2026	NAI	Chicago District Office	Compliance: Medical Devices
September 8, 2023	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
October 30, 2019	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 4, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices