FDA Inspection
Big River Engineering and ManufacturingBig River Engineering and Manufacturing – FDA Inspection, Jan 15, 2015
Record Details
This FDA Inspection record concerns Big River Engineering and Manufacturing, with an inspection on January 15, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 15, 2015
- Product Type
- Devices
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ID · 142e311b-618e-447d-b543-144b817647e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 911619
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Big River Engineering and Manufacturing
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 14, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Big River Engineering and Manufacturing
- FDA Inspection 1164251 - 2022-02-16
- FDA Inspection 978243 - 2016-06-14
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