Dr. Martin Schaich
Managing Director
Fischer Analysen Instrumente Gmbh
Brahestr. 25-27
Leipzig
04347 Saxony
Germany
Martin.Schaich@fan-gmbh.deFEI 3010837197Issued Feb 3, 2023Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010837197.
Violations15
Issue DateFeb 3, 2023
Product TypeMedical Devices
StatusClosed
Closeout LetterJul 15, 2024
Letter Details
Firm
Fischer Analysen Instrumente Gmbh
Location
Dr. Martin Schaich
Managing Director
Fischer Analysen Instrumente Gmbh
Brahestr. 25-27
Leipzig
04347 Saxony
Germany
Martin.Schaich@fan-gmbh.de
FEI Number
3010837197
Country
Germany
Issue Date
February 03, 2023
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Closed
Closeout Letter
July 15, 2024
Summary
Fischer Analysen Instrumente Gmbh, a German manufacturer of the PyloPlus UBT System 13/12CO2 breathing gas analyzer (a diagnostic medical device), failed to comply with FDA's Current Good Manufacturing Practice requirements under 21 CFR Part 820. During a November 2022 inspection, the FDA identified inadequate documentation of device software validation, including missing software revision plans and undocumented input specification requirements for software revision 1.49. These deficiencies rendered the devices adulterated and non-compliant with quality system regulations governing medical device manufacturing and controls.
Fischer Analysen Instrumente Gmbh FDA Warning Letter, February 3, 2023
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