FDA Inspection
Trilliant Surgical, LLCTrilliant Surgical, LLC – FDA Inspection, Jan 20, 2010
Record Details
This FDA Inspection record concerns Trilliant Surgical, LLC, with an inspection on January 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Trilliant Surgical, LLC
- Inspection Date
- January 20, 2010
- Product Type
- Devices
View Company Profile
ID · 73679eec-fca7-4b2b-99d2-0d24c43f1af4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 631967
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.50(b)Approval, inadequate purchasing data
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Trilliant Surgical, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 2, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 27, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 12, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 9, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Trilliant Surgical, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.