Koros USA, Inc. – FDA Inspection, Nov 14, 2016

Record Details

This FDA Inspection record concerns Koros USA, Inc., with an inspection on November 14, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: Koros USA, Inc.
Inspection Date: November 14, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Janet Pulver (FDA Associated Person)

View Company Profile

ID · bc83cb4f-9a4a-4bc3-a4d7-bae14c3397de

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 991885
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.80(e)Documentation
21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.120Lack of or inadequate procedures for labeling
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.180(b)Retention period

Showing 10 of 12 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Koros USA, Inc.

Date	Classification	Office	Project area
December 19, 2024	NAI	Los Angeles District Office	Postmarket Assurance: Medical Devices
February 16, 2022	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
February 14, 2014	VAI	Center for Devices and Radiological Health	Compliance: Devices
September 23, 2010	VAI	Center for Devices and Radiological Health	Compliance: Devices