Company
SwedenBoule Medical AB, Spanga, Sweden – FDA Inspections
Inspection records and compliance data for Boule Medical AB in Spanga. 4 FDA inspections on record (1 OAI), 2 Form 483s, last inspected February 19, 2026.
Company Profile
This profile covers Boule Medical AB based in Spanga, Sweden.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected February 6, 2014. Last inspected February 19, 2026.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Management ensuring quality policy is understood1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 19, 2026 | Not classified | Medical Devices & Rad Health | 1308308 |
| July 11, 2019 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1098253 |
| May 11, 2018 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1053546 |
| February 6, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 867558 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Boule Medical AB
FEI Number
3004008703
Address
Domnarvsgatan 4, Spanga, Sweden
Country
Sweden
ID: 39288ca9-46b0-407c-9e54-70a7145ae878