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Rontis Hellas S.A., a Greek medical device manufacturer, was found to have produced Cronus HP PTA OTW Balloon Catheters in violation of current Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820, specifically failing to validate manufacturing processes with adequate assurance and obtain proper approvals. During a July 2024 inspection, investigators identified deficiencies in the company's sterilization validation procedures, including inadequate validation of ethylene oxide (EtO) sterilization processes according to ISO 11135-1:2007 standards. The firm's responses to the FDA's inspectional observations in August and September 2024 did not adequately address the documented compliance gaps.