FDA Inspection
Beacon Bio Dx LLCBeacon Bio Dx LLC – FDA Inspection, Jul 7, 2017
Record Details
This FDA Inspection record concerns Beacon Bio Dx LLC, with an inspection on July 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f8dc2e4f-1331-4df0-9f20-fb33af1229d3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1017346
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.111(a)(2)Risks to subjects reasonable
- 21 CFR 56.111(a)(3)Selection of subjects equitable
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
- 21 CFR 56.111 (a)(2)Risks to subjects reasonable
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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 28, 2023 | VAI | Center for Devices and Radiological Health | Compliance: 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 1210967 - 2023-07-28
- FDA Inspection 912729 - 2015-02-05
- FDA Inspection 725918 - 2011-06-01
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