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FDA Inspection
•TriMed Inc.•January 25, 2012

TriMed Inc. – FDA Inspection, Jan 25, 2012

Record Details

This FDA Inspection record concerns TriMed Inc., with an inspection on January 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company
TriMed Inc.
Inspection Date
January 25, 2012
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 77156831-8c85-4df6-90f2-cdfa5436d1a2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
766423
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

5
  1. 21 CFR 803.50(a)(2)Individual Report of Malfunction
  2. 21 CFR 820.198(c)Investigation of device failures
  3. 21 CFR 820.72(a)Equipment control activity documentation
  4. 21 CFR 820.22Quality Audits - defined intervals
  5. 21 CFR 820.30(j)Design history file

Full citation text and observation details available on the Dashboard.

Other FDA inspections of TriMed Inc.

5
DateClassificationOfficeProject area
June 3, 2024Not classifiedLos Angeles District OfficeCompliance: Devices
August 14, 2019NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
November 17, 2017VAICenter for Devices and Radiological HealthCompliance: Devices
January 12, 2017VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
March 18, 2016OAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for TriMed Inc.
  • FDA Inspection 1240179 - 2024-06-03
  • FDA Inspection 1103478 - 2019-08-14
  • FDA Inspection 1031588 - 2017-11-17
  • FDA Inspection 998813 - 2017-01-12
  • FDA Inspection 963328 - 2016-03-18

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