FDA Inspection
Bioplate IncBioplate Inc – FDA Inspection, Jun 1, 2026
Record Details
This FDA Inspection record concerns Bioplate Inc, with an inspection on June 1, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · 5b566f6f-e5ba-43d9-80ae-ea7a3a2e3bab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1320108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.1Planning of product realization not consistent with other QMS processes
- ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 8.2.1Feedback process procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bioplate Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 2, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 1, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bioplate Inc
- FDA Inspection 1037318 - 2017-10-25
- FDA Inspection 885905 - 2014-07-02
- FDA Inspection 743472 - 2011-09-01
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