FDA WARNING_LETTER - Rontis Hellas S.A. - July 25, 2024

An FDA inspection of Industrial Area of Larissa, Greece, from July 22-25, 2024, revealed that the firm's Cronus HP PTA OTW Balloon Catheter devices are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation 21 CFR Part 820, specifically a failure to validate processes with a high degree of assurance as required by 21 CFR 820.75(a). This included issues with EtO sterilization validation, such as performing validation without EtO gas, inadequate justification for product selection, and undocumented product adoption. The devices are also misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required Medical Device Reporting (MDR) information per 21 CFR Part 803. The firm's written MDR procedures (RC_SOP-10-003) were found inadequate, lacking internal systems for timely event identification, evaluation, and communication (21 CFR 803.17(a)(1)), a standardized review process (21 CFR 803.17(a)(2)), and timely transmission of complete reports (21 CFR 803.17(a)(3)). Furthermore, documentation and recordkeeping requirements were not adequately addressed (21 CFR 803.17(b)). Despite revisions, the procedure continued to fail in establishing timely identification/evaluation and transmission systems. Critically, the firm lacked an active ESG production account for electronic MDR submissions. The FDA deemed the firm's responses inadequate and requires a written response within fifteen business days detailing corrective actions, prevention plans, and a timeline for systemic improvements. Failure to comply may impact federal contracts and Class III device approvals.