TriMed Inc. – FDA Inspection, Jan 12, 2017

Record Details

This FDA Inspection record concerns TriMed Inc., with an inspection on January 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: TriMed Inc.
Inspection Date: January 12, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Janet Pulver (FDA Associated Person)

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ID · 41725b43-31fb-474d-b3ef-d5fc171af2d2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 998813
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.40Lack of procedures, or not maintained
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 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.120Lack of or inadequate procedures for labeling
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
March 18, 2016	OAI	Center for Devices and Radiological Health	Compliance: Devices
January 25, 2012	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices