F Care Systems USA, LLC – FDA Inspection, Mar 30, 2012

Record Details

This FDA Inspection record concerns F Care Systems USA, LLC, with an inspection on March 30, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: F Care Systems USA, LLC
Inspection Date: March 30, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 5d247698-7a30-4c89-86c2-8a44b85d2807

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 774386
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.184DHR - not or inadequately maintained
21 CFR 820.198(a)Complaints
21 CFR 820.160(b)Distribution records
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.72(a)Equipment control activity documentation
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
21 CFR 820.120Lack of or inadequate procedures for labeling

Showing 10 of 11 citations.

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Other FDA inspections of F Care Systems USA, LLC

Date	Classification	Office	Project area
November 27, 2023	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
March 21, 2022	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
March 6, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
December 5, 2012	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices