Boule Medical AB

Form 483FOIA Uncovered

Spanga, -FEI 3004008703Issued May 11, 2018

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3004008703.

ObservationsNot available

Issue DateMay 11, 2018

Status1 Related Warning Letter

Related Inspections3

Establishment Details

Firm: Boule Medical AB
Location: Spanga, -
FEI Number: 3004008703
Product Type: Devices
Issue Date: May 11, 2018
Country: United States

Inspection History, 2014 to 2026

NAI1

VAI1

OAI1

NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.

Act on This Form 483

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Boule Medical AB FDA Form 483, Spanga, May 11, 2018