Fisioline s.r.l. – FDA Warning Letter, Nov 1, 2012

An FDA inspection of Fisioline, s.r.l in Verduno, Italy, from October 29 to November 1, 2012, revealed that the firm's Lumix 2 and Lumix 3 laser devices are adulterated and misbranded. The devices are adulterated under section 501(h) of the Act because manufacturing methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). They are misbranded under section 502(t)(2) for failing to provide information required by the Medical Device Reporting (MDR) regulation (21 CFR Part 803). The firm's response to the FDA 483 was not reviewed due to late submission. Significant QS violations include failures in establishing and maintaining procedures for complaint handling (21 CFR 820.198(a), (b), (e)), computer software validation (21 CFR 820.70(i)), device design validation, verification, and review (21 CFR 820.30(g), (f), (e)), corrective and preventive action (21 CFR 820.100(a)), nonconforming product disposition (21 CFR 820.90(b)(1)), equipment calibration and documentation (21 CFR 820.72(a), (b)(2)), acceptance activities documentation (21 CFR 820.80(e)), and quality audits (21 CFR 820.22). Additionally, the firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Fisioline must notify the FDA within fifteen business days with specific corrective actions, including systemic changes and a timetable for implementation. Failure to correct these violations may impact federal contracts, premarket approvals for Class III devices, and the granting of Certificates to Foreign Governments.