TriMed Inc. – FDA Inspection, Mar 18, 2016

Record Details

This FDA Inspection record concerns TriMed Inc., with an inspection on March 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: TriMed Inc.
Inspection Date: March 18, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · d6b15ac5-45ea-43a3-9be1-ee0e0f7efeed

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 963328
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.140Lack of or inadequate procedures for handling
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate

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Other FDA inspections of TriMed Inc.

Date	Classification	Office	Project area
June 3, 2024	Not classified	Los Angeles District Office	Compliance: Devices
August 14, 2019	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
November 17, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
January 12, 2017	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
January 25, 2012	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices