Argon Medical Productions & Vertrieb Gesellschaft MBH & CO

Warning LetterOpen

Mr. Richard Donaca CEO Argon Medical Productions & Vertrieb Gesellschaft MBH & CO Franz Kirsten Str. 1 Bingen Am-Rhein 55411 Rhineland-Palatinate Germany r.donaca@argon-group.deFEI 3011575197Issued Nov 22, 2024Center for Devices and Radiological Health

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Violations9

Issue DateNov 22, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Argon Medical Productions & Vertrieb Gesellschaft MBH & CO
Location: Mr. Richard Donaca CEO Argon Medical Productions & Vertrieb Gesellschaft MBH & CO Franz Kirsten Str. 1 Bingen Am-Rhein 55411 Rhineland-Palatinate Germany r.donaca@argon-group.de
FEI Number: 3011575197
Country: Germany
Issue Date: November 22, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Argon Medical Productions manufactured dental implant systems (K3Pro and related abutments) that were found to be adulterated due to failures to comply with current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. The inspection conducted July 29-31, 2024, at the firm's facility in Bingen am-Rhein, Germany identified violations including failure to properly review, evaluate, and investigate complaints involving potential device failures and labeling issues as required by 21 CFR 820.198(c). The company's August 2024 response to FDA's inspectional observations was deemed inadequate to address the identified compliance deficiencies.

Argon Medical Productions & Vertrieb Gesellschaft MBH & CO FDA Warning Letter, November 22, 2024