FDA Inspection
Beacon Bio Dx LLCBeacon Bio Dx LLC – FDA Inspection, Sep 1, 2026
Record Details
This FDA Inspection record concerns Beacon Bio Dx LLC, with an inspection on September 1, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
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ID · da328eef-f501-40f2-ab77-ecd7f74c616b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1333866
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.1Processes needed for product realization not planned and developed
- ISO 13485:2016 Clause 7.3.4Design and development outputs not adequate
- ISO 13485:2016 Clause 7.3.9Records of design and development changes and their reviews not maintained
- ISO 13485:2016 Clause 7.4.1Results of supplier monitoring not used as input into the supplier re-evaluation
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Other FDA inspections of Beacon Bio Dx LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2023 | VAI | Center for Devices and Radiological Health | Compliance: 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 1210967 - 2023-07-28
- FDA Inspection 1017346 - 2017-07-07
- FDA Inspection 912729 - 2015-02-05
- FDA Inspection 725918 - 2011-06-01
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