FDA Inspection
Beacon Bio Dx LLCBeacon Bio Dx LLC – FDA Inspection, Jul 28, 2023
Record Details
This FDA Inspection record concerns Beacon Bio Dx LLC, with an inspection on July 28, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 622e3170-283f-4e64-9c82-50acb2c3d1f6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210967
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Beacon Bio Dx LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2026 | NAI | Cincinnati District Office | Postmarket Assurance: Devices |
| July 7, 2017 | OAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| February 5, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 1, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Beacon Bio Dx LLC
- FDA Inspection 1333866 - 2026-09-01
- FDA Inspection 1017346 - 2017-07-07
- FDA Inspection 912729 - 2015-02-05
- FDA Inspection 725918 - 2011-06-01
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