FDA WARNING_LETTER - Future Diagnostics Solutions B.V. - January 19, 2023

An FDA inspection of Nieuweweg 279 in Gelderland, Netherlands, from January 16-19, 2023, revealed that the firm's STAT-IntraOperative-Intact PTH Immunoassay Kits are adulterated and misbranded. The devices are adulterated because manufacturing methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). Specific QS violations include failure to verify CAPA effectiveness (21 CFR 820.100(a)(4)), inadequate procedures for controlling nonconforming product (21 CFR 820.90(a)), lack of established statistical techniques and adequate sampling plans (21 CFR 820.250), and failure to adequately establish and conduct quality audits (21 CFR 820.22). The devices are also misbranded due to the firm's failure to furnish required Medical Device Reporting (MDR) information (21 CFR Part 803). MDR violations include inadequate written MDR procedures (21 CFR 803.17(a)) and failure to submit timely MDR reports for device malfunctions (21 CFR 803.50(a)(2)). The firm must respond within fifteen business days with specific corrective actions, documentation, and a timetable for systemic issues. Non-compliance may affect federal contracts and Class III device approvals.