FDA Inspection
Aurora Manufacturing LLCAurora Manufacturing LLC – FDA Inspection, Oct 31, 2016
Record Details
This FDA Inspection record concerns Aurora Manufacturing LLC, with an inspection on October 31, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b3314c20-95d8-4d07-ba6c-e6aad1a66a29
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993759
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.184DHR content
- 21 CFR 820.50(b)Supplier notification of changes
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Other FDA inspections of Aurora Manufacturing LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 19, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 10, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Aurora Manufacturing LLC
- FDA Inspection 834441 - 2013-04-19
- FDA Inspection 670670 - 2009-11-10
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