FDA Inspection
bioMerieux, Inc.bioMerieux, Inc. – FDA Inspection, Apr 10, 2017
Record Details
This FDA Inspection record concerns bioMerieux, Inc., with an inspection on April 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bba2d119-61ae-4ce1-ac29-951091d706b8
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1015629
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of bioMerieux, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 5, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 14, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 6, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for bioMerieux, Inc.
- FDA Inspection 961531 - 2016-01-05
- FDA Inspection 837677 - 2013-06-14
- FDA Inspection 772522 - 2012-03-06
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