FDA Inspection
Tegra Medical, LLCTegra Medical, LLC – FDA Inspection, Jan 20, 2012
Record Details
This FDA Inspection record concerns Tegra Medical, LLC, with an inspection on January 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tegra Medical, LLC
- Inspection Date
- January 20, 2012
- Product Type
- Devices
View Company Profile
ID · dccd3503-09c2-4c1d-abc2-48b8781f35a7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 768849
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
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Other FDA inspections of Tegra Medical, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tegra Medical, LLC
- FDA Inspection 570521 - 2009-03-18
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