FDA Inspection
Trillium Technology, Inc.Trillium Technology, Inc. – FDA Inspection, Apr 30, 2018
Record Details
This FDA Inspection record concerns Trillium Technology, Inc., with an inspection on April 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Amy S. Graf (Issuing Officer)
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ID · 1de373ef-d0e5-4ffa-9283-7aa47aec5bbc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1050135
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Trillium Technology, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 20, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Trillium Technology, Inc.
- FDA Inspection 911428 - 2015-01-30
- FDA Inspection 838130 - 2013-06-28
- FDA Inspection 745386 - 2011-09-20
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