FDA WARNING_LETTER - Herniamesh S.r.l - July 23, 2015

This FDA Warning Letter, issued to Herniamesh S.r.l. following an inspection in Chivasso, Italy, from July 20-23, 2015, identifies significant violations of the Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803) for their polymeric surgical meshes. The devices are deemed adulterated and misbranded. Key QS violations include failure to establish and maintain procedures for complaint handling, adequately validate processes like Tyvek packaging, monitor validated processes, establish incoming product acceptance procedures with statistical rationale, validate computer software used in production and the quality system, and establish proper calibration procedures. The firm's responses to these observations were deemed inadequate, often lacking retrospective reviews, risk analyses, or sufficient documentation. Additionally, the firm failed to report serious injuries within 30 days and adequately develop, maintain, and implement written MDR procedures, including lacking definitions for "reasonably suggests" and procedures for supplemental reports. As a result of these serious violations, Herniamesh's polymeric surgical meshes are subject to refusal of admission into the U.S. (detention without physical examination). The firm must provide a written response within fifteen business days detailing corrective actions, including systemic changes, a timetable for completion, and supporting documentation. Failure to correct violations will also impact premarket approval applications for Class III devices and federal contracts.