Frontier Medical Products Inc. – FDA Inspection, Mar 10, 2011

Record Details

This FDA Inspection record concerns Frontier Medical Products Inc., with an inspection on March 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Frontier Medical Products Inc.
Inspection Date: March 10, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 186a39be-3c45-4c05-8709-ad35ca95d505

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 712806
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.22Quality audits - auditor independence
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.184DHR content
21 CFR 820.20(b)Lack of or inadequate organizational structure

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Other FDA inspections of Frontier Medical Products Inc.

Date	Classification	Office	Project area
March 22, 2018	NAI	Center for Devices and Radiological Health	Compliance: Devices
January 10, 2013	VAI	Center for Devices and Radiological Health	Compliance: Devices
January 27, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices
July 9, 2010	OAI	Center for Devices and Radiological Health	Compliance: Devices