FDA WARNING_LETTER - MKL DIAGNOSTICS AB - March 25, 2014

An FDA inspection of MKL Diagnostics AB in Sollentuna, Sweden, from March 24-25, 2014, revealed that the firm's Phadebact monoclonal GC, H. Influenza, and CSF Tests are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) because manufacturing methods, facilities, or controls do not conform to the Quality System regulation (21 CFR Part 820). Specific violations include the failure to establish and maintain design control procedures (21 CFR 820.30(a)) and the failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints, particularly regarding Medical Device Reporting (MDR) reportability (21 CFR 820.198(a)(3)). Furthermore, the devices are misbranded under 21 U.S.C. § 352(t)(2) due to the firm's failure to furnish required information under section 519 of the Act and 21 CFR Part 803, specifically by not developing, maintaining, and implementing written MDR procedures (21 CFR 803.17). The FDA requires the firm to respond within fifteen business days, detailing specific corrective actions, prevention plans, and supporting documentation, including a timetable for any ongoing activities. Failure to correct these violations may impact federal contracts and premarket approval applications for Class III devices. This letter emphasizes the firm's responsibility to ensure overall compliance with FDA regulations.