FDA Inspection
Myriad Fiber Imaging Technologies, Inc.Myriad Fiber Imaging Technologies, Inc. – FDA Inspection, Sep 18, 2015
Record Details
This FDA Inspection record concerns Myriad Fiber Imaging Technologies, Inc., with an inspection on September 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 18, 2015
- Product Type
- Devices
View Company Profile
ID · 7d70944e-e4e4-4395-b068-3c3a3c56bce6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 944253
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Myriad Fiber Imaging Technologies, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2025 | NAI | New England District Office | Postmarket Assurance: Medical Devices |
| July 29, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Myriad Fiber Imaging Technologies, Inc.
- FDA Inspection 1277076 - 2025-07-31
- FDA Inspection 1175802 - 2022-07-29
- FDA Inspection 770124 - 2012-02-07
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.