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My DashboardInspection TrackerWarning LettersI.T.S. GmbH

All Warning Letters

I.T.S. GmbH

Warning LetterOpen

Autal 28 Lassnithohe 8301 Steiermark AustriaIssued May 19, 2023Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations7

Issue DateMay 19, 2023

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: I.T.S. GmbH
Location: Autal 28 Lassnithohe 8301 Steiermark Austria
FEI Number: N/A
Country: N/A
Issue Date: May 19, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated

I.T.S. GmbH FDA Warning Letter, May 19, 2023