FDA Inspection
Trillium Technology, Inc.Trillium Technology, Inc. – FDA Inspection, Sep 20, 2011
Record Details
This FDA Inspection record concerns Trillium Technology, Inc., with an inspection on September 20, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Trillium Technology, Inc.
- Inspection Date
- September 20, 2011
- Product Type
- Devices
View Company Profile
ID · 07c517d6-6ddc-4acf-a7b5-74819b5aac87
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 745386
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.40(a)Document review, approval documentation
- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Trillium Technology, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 |
Other documents for Trillium Technology, Inc.
- FDA Inspection 1050135 - 2018-04-30
- FDA Inspection 911428 - 2015-01-30
- FDA Inspection 838130 - 2013-06-28
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