FDA Inspection
Biomerics, LLCBiomerics, LLC – FDA Inspection, Feb 28, 2017
Record Details
This FDA Inspection record concerns Biomerics, LLC, with an inspection on February 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f225f996-b75e-46cc-90bd-212c6270af77
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006556
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.72(b)Remedial action
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Other FDA inspections of Biomerics, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 17, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 10, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 22, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 21, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biomerics, LLC
- FDA Inspection 1045746 - 2018-03-06
- FDA Inspection 951919 - 2015-08-17
- FDA Inspection 937639 - 2015-07-10
- FDA Inspection 858455 - 2013-11-22
- FDA Inspection 776090 - 2012-03-21
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