FDA Inspection
Boule Medical ABBoule Medical AB – FDA Inspection, May 11, 2018
Record Details
This FDA Inspection record concerns Boule Medical AB, with an inspection on May 11, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · afa5f328-f80f-41d4-a959-4ddae21e741f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1053546
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Boule Medical AB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2026 | Not classified | Office of Inspections and Investigations | |
| July 11, 2019 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| February 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Boule Medical AB
- FDA Inspection 1308308 - 2026-02-19
- FDA Inspection 1098253 - 2019-07-11
- FDA Inspection 867558 - 2014-02-06
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