FDA Inspection
BSN Medical IncBSN Medical Inc – FDA Inspection, Nov 8, 2017
Record Details
This FDA Inspection record concerns BSN Medical Inc, with an inspection on November 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 8b9efed3-d58a-403f-b85d-4f9fbc3e1e94
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030983
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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Other FDA inspections of BSN Medical Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2025 | NAI | Atlanta District Office | Postmarket Assurance: Medical Devices |
| March 22, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BSN Medical Inc
- FDA Inspection 1280555 - 2025-09-05
- FDA Inspection 1136920 - 2021-03-22
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