FDA Inspection
Biometerplususa Inc.Biometerplususa Inc. – FDA Inspection, Mar 25, 2026
Record Details
This FDA Inspection record concerns Biometerplususa Inc., with an inspection on March 25, 2026, issued by the San Francisco District Office, covering medical devices & rad health.
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ID · 376d11e3-af1a-4aac-90b5-f1e4105c62c3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1309260
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
6- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 7.5.8No documented system to assign unique device identification (UDI)
- ISO 13485:2016 Clause 4.1.3Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.6(a)Measuring equipment not adequately calibrated or verified
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biometerplususa Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 3, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 14, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 25, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biometerplususa Inc.
- FDA Inspection 981334 - 2016-07-21
- FDA Inspection 722592 - 2011-05-03
- FDA Inspection 658684 - 2010-05-14
- FDA Inspection 615040 - 2009-09-25
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