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FDA Inspection
•Trilliant Surgical, LLC•September 9, 2011

Trilliant Surgical, LLC – FDA Inspection, Sep 9, 2011

Record Details

This FDA Inspection record concerns Trilliant Surgical, LLC, with an inspection on September 9, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
Trilliant Surgical, LLC
Inspection Date
September 9, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 6e29f7d1-16e2-4f1a-8219-588621ac25cb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
735413
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.22Quality audits - auditor independence
  3. 21 CFR 820.22Quality Audit/Reaudit - conducted

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Trilliant Surgical, LLC

5
DateClassificationOfficeProject area
December 11, 2019VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
May 2, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
June 27, 2016OAICenter for Devices and Radiological HealthCompliance: Devices
February 12, 2015OAICenter for Devices and Radiological HealthCompliance: Devices
January 20, 2010OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Trilliant Surgical, LLC
  • FDA Inspection 1112397 - 2019-12-11
  • FDA Inspection 1050711 - 2018-05-02
  • FDA Inspection 984202 - 2016-06-27
  • FDA Inspection 913623 - 2015-02-12
  • FDA Inspection 631967 - 2010-01-20

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