FDA Inspection
Bionix, LlcBionix, Llc – FDA Inspection, Jul 14, 2026
Record Details
This FDA Inspection record concerns Bionix, Llc, with an inspection on July 14, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · e6874ab6-4d74-4e0e-b4f2-94cf12046a80
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1326218
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.198(e)Records of complaint investigation - UDI
- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.6Design and development verification not performed
- ISO 13485:2016 Clause 7.4.1Supplier evaluation and selection criteria do not include required elements
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 8.4Procedures for analysis of data not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bionix, Llc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 24, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 23, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 21, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 17, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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