Frontier Medical Products Inc. – FDA Inspection, Jan 27, 2012

Record Details

This FDA Inspection record concerns Frontier Medical Products Inc., with an inspection on January 27, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Frontier Medical Products Inc.
Inspection Date: January 27, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · e395002e-2ac4-4939-a85a-82451ae896fe

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 764789
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.184DHR - not or inadequately maintained
21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.25(a)Personnel
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures

Showing 10 of 12 citations.

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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
March 10, 2011	VAI	Center for Devices and Radiological Health	Compliance: Devices
July 9, 2010	OAI	Center for Devices and Radiological Health	Compliance: Devices