FDA inspection
Boule Medical AB: FDA inspection ending May 11, 2018
FDA inspection 1053546 · Official Action Indicated (OAI) · Spanga
Key facts
| Inspection ID | 1053546 |
|---|---|
| Firm | Boule Medical AB |
| FEI number | 3004008703 |
| Address | Domnarvsgatan 4 |
| City | Spanga |
| Country | Sweden |
| Fiscal year | 2018 |
| Inspection end date | May 11, 2018 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 559614 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data