FDA Inspection
Boule Medical ABBoule Medical AB – FDA Inspection, Jul 11, 2019
Record Details
This FDA Inspection record concerns Boule Medical AB, with an inspection on July 11, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 35e3098b-71da-46ca-943e-fa05778a3b1d
Inspection Facts
- Inspection number
- 1098253
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(a)Management ensuring quality policy is understood
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Other FDA inspections of Boule Medical AB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 19, 2026 | Not classified | Office of Inspections and Investigations | |
| May 11, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1053546 - 2018-05-11
- FDA Inspection 867558 - 2014-02-06
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