FDA WARNING_LETTER - Ortec - January 09, 2025

The FDA issued a Warning Letter to Jagerhofstr. 17 in Numbrecht, Germany, after a January 2025 inspection revealed significant Quality System Regulation (QSR) violations for their SAFE-TFILL Capillary Blood Collection Systems. These devices were deemed adulterated under 21 U.S.C. § 351(h) due to non-conformity with current good manufacturing practices (21 CFR Part 820).

Major deficiencies included: failure to validate manufacturing processes and software (21 CFR 820.75(a)); inadequate equipment qualification (21 CFR 820.70(g)); lack of established design control procedures and inadequate design history files (21 CFR 820.30(a)); deficient corrective and preventive action (CAPA) procedures and investigations (21 CFR 820.100(a)); failure to control nonconforming product, including documentation of disposition (21 CFR 820.90); inconsistent supplier management and quality agreements (21 CFR 820.50); and failure to develop and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17).

The firm's initial response was inadequate, lacking evidence of systemic corrective actions, revised procedures, or implementation plans. As a result, all devices are subject to refusal of admission into the U.S. The firm must submit a comprehensive written response within fifteen business days, detailing specific, systemic corrective actions, supporting documentation, and a timetable to address these critical compliance issues and prevent recurrence.