Boule Medical AB

Form 483

Spanga, -, SwedenFEI 3004008703Issued February 06, 2014

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.

Observations3

Issue DateFebruary 06, 2014

Status1 Related Warning Letter

Related Inspections3

Establishment Details

Firm: Boule Medical AB
Location: Spanga, -, Sweden
FEI Number: 3004008703
Product Type: Devices
Issue Date: February 06, 2014
Country: Sweden

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

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Boule Medical AB FDA Form 483, Spanga, February 6, 2014