FDA inspection

Boule Medical AB: FDA inspection ending Nov 10, 2022

FDA inspection 1191842 · Voluntary Action Indicated (VAI) · Spanga

Key facts

Inspection ID	1191842
Firm	Boule Medical AB
FEI number	3004008703
Address	Domnarvsgatan 4
City	Spanga
Fiscal year	2023
Inspection end date	Nov 10, 2022
Classification	Voluntary Action Indicated (VAI)
Project area	Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices
Product type	Devices

At a glance

1–9 Citations
1–9 Posted citations
No 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

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