Champion Mfg Inc – FDA Inspection, Jul 8, 2011

Record Details

This FDA Inspection record concerns Champion Mfg Inc, with an inspection on July 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Champion Mfg Inc
Inspection Date: July 8, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · c582dd89-069a-4472-9469-5a6293bf1079

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 734934
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: 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 820.25(b)Training records
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.80(c)Lack of or inadequate In-process acceptance 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 not performed/inadequate

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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