Frontier Medical Products Inc. – FDA Inspection, Jul 9, 2010

Record Details

This FDA Inspection record concerns Frontier Medical Products Inc., with an inspection on July 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Frontier Medical Products Inc.
Inspection Date: July 9, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · fcca74b2-9aff-479b-9648-37e74276fb8f

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 665656
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 820.198(a)Complaints
21 CFR 820.40(a)Not approved or obsolete document retrieval
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
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 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.22Quality Audits - defined intervals

Showing 10 of 11 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
January 27, 2012	VAI	Center for Devices and Radiological Health	Compliance: Devices
March 10, 2011	VAI	Center for Devices and Radiological Health	Compliance: Devices