FDA Inspection
Tricor SystemsTricor Systems – FDA Inspection, Mar 8, 2023
Record Details
This FDA Inspection record concerns Tricor Systems, with an inspection on March 8, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · bff37e39-710e-4225-becc-36d60036aa5b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199278
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tricor Systems
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 24, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 9, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tricor Systems
- FDA Inspection 928462 - 2015-05-21
- FDA Inspection 711086 - 2011-02-24
- FDA Inspection 554108 - 2008-10-09
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.