# Boule Medical AB, Spanga, Sweden – FDA Inspections

Source: https://www.keypedia.com/companies/boule-medical-ab/39288ca9-46b0-407c-9e54-70a7145ae878

> 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.

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## Details

- Name: Boule Medical AB
- FEI Number: 3004008703
- Address Line 1: Domnarvsgatan 4
- City: Spanga
- Country Name: Sweden
- Address: Domnarvsgatan 4, Spanga, Sweden
- Country: Sweden

## Related Documents

- FDA Inspection 1308308 - Boule Medical AB - 2026-02-19 — source: FDA, date: February 19, 2026
- [FDA Inspection 1098253 - Boule Medical AB - 2019-07-11](https://www.keypedia.com/records/fda_inspections/boule-medical-ab/35e3098b-71da-46ca-943e-fa05778a3b1d) — source: FDA, date: July 11, 2019
- [483 - Boule Medical AB - 2018-05-11](https://www.keypedia.com/records/483/boule-medical-ab/337c4dfd-f1c7-4770-844a-75e4d566c4ca) — source: FDA, date: May 11, 2018
- [FDA Inspection 1053546 - Boule Medical AB - 2018-05-11](https://www.keypedia.com/records/fda_inspections/boule-medical-ab/afa5f328-f80f-41d4-a959-4ddae21e741f) — classification: Official Action Indicated (OAI), source: FDA, date: May 11, 2018
- FDA Inspection 1053546 - Boule Medical AB - 2018-05-11 — classification: Official Action Indicated (OAI), source: FDA, date: May 11, 2018
- FDA Inspection 867558 - Boule Medical AB - 2014-02-06 — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 6, 2014
- FDA Inspection 867558 - Boule Medical AB - 2014-02-06 — classification: No Action Indicated (NAI), source: FDA, date: February 6, 2014

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