FDA Inspection
Trek Diagnostics Systems Inc. (dba Thermo Fisher Scientific)Trek Diagnostics Systems Inc. (dba Thermo Fisher Scientific) – FDA Inspection, Feb 7, 2012
Record Details
This FDA Inspection record concerns Trek Diagnostics Systems Inc. (dba Thermo Fisher Scientific), with an inspection on February 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 7, 2012
- Product Type
- Devices
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ID · 39c57932-f5e9-4f46-bf5f-fddea6f1a8f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770957
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Trek Diagnostics Systems Inc. (dba Thermo Fisher Scientific)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 16, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Trek Diagnostics Systems Inc. (dba Thermo Fisher Scientific)
- FDA Inspection 570301 - 2009-03-16
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