FDA Inspection
Biomerics Precision Concepts GroupBiomerics Precision Concepts Group – FDA Inspection, May 21, 2026
Record Details
This FDA Inspection record concerns Biomerics Precision Concepts Group, with an inspection on May 21, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
- Inspection Date
- May 21, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 38c8fe00-6b51-480d-a2c2-8d99454a8ecb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1318162
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
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Other FDA inspections of Biomerics Precision Concepts Group
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 9, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biomerics Precision Concepts Group
- FDA Inspection 1117676 - 2019-12-12
- FDA Inspection 917552 - 2015-03-09
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