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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.