FDA Inspection
Breas Medical ABBreas Medical AB – FDA Inspection, Mar 5, 2015
Record Details
This FDA Inspection record concerns Breas Medical AB, with an inspection on March 5, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Breas Medical AB
- Inspection Date
- March 5, 2015
- Product Type
- Devices
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ID · 7b872cf7-7aed-4128-9b27-caee1c4fca7a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 918031
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 820.198(d)Evaluation, timeliness, identification
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Other FDA inspections of Breas Medical AB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 18, 2018 | Not classified | Office of Inspections and Investigations | |
| March 25, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Breas Medical AB
- FDA Inspection 1177717 - 2022-08-10
- FDA Inspection 1121481 - 2018-10-18
- FDA Inspection 658062 - 2010-03-25
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