A.R.C. LASER GMBH – FDA Warning Letter, Aug 8, 2013

The FDA issued a Warning Letter to A.R.C. Laser GmbH following an August 2013 inspection in Nurnberg, Germany, for manufacturing misbranded medical lasers. The firm failed to furnish required information under 21 CFR Part 803 (Medical Device Reporting - MDR) Regulation. Key violations include the failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17), lacking systems for timely event identification, communication, evaluation, and a standardized review process. MDR procedures also lacked evidence of implementation. Additional Quality System regulation (21 CFR Part 820) nonconformances were cited: Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), with deficiencies in data analysis, action verification, and documentation; Failure to maintain complaint files and establish procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)), specifically regarding uniform processing, oral complaint documentation, and MDR reportability; Failure to review and evaluate complaints, and document reasons for non-investigation and responsible personnel (21 CFR 820.198(b)); and Failure to establish calibration procedures with remedial action provisions when accuracy limits are not met (21 CFR 820.72(b)). The firm's responses were inadequate, lacking evidence of implementation, comprehensive data analysis, or employee training. A.R.C. Laser GmbH must provide a written response within fifteen business days detailing specific corrective actions, prevention plans, and a timetable. Uncorrected violations could affect Class III device premarket approvals and federal contract awards.