Champion Mfg Inc – FDA Inspection, Jun 3, 2010

Record Details

This FDA Inspection record concerns Champion Mfg Inc, with an inspection on June 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Champion Mfg Inc
Inspection Date: June 3, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · db784348-0234-4a17-8bd2-653804876b2b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 666070
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.80(c)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(e)Records of complaint investigation
21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
21 CFR 820.30(g)Design validation - Risk analysis
21 CFR 820.30(j)Design history file

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Other FDA inspections of Champion Mfg Inc

Date	Classification	Office	Project area
May 22, 2025	VAI	Florida District Office	Compliance: Medical Devices
July 12, 2018	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 27, 2015	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
February 21, 2014	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 14, 2011	VAI	Center for Devices and Radiological Health	Compliance: Devices