FDA WARNING_LETTER - Teleflex Medical - September 24, 2013

An FDA inspection of Teleflex Incorporated's Arlington Heights, Illinois facility, conducted from August 27 to September 24, 2013, revealed significant violations of the Quality System regulation (21 CFR Part 820) for its Class II nebulizer, humidifier, and respiratory gas devices. These devices are deemed adulterated under Section 501(h) of the Act. Key deficiencies included the failure to adequately establish procedures for corrective and preventive action (21 CFR 820.100(a)), failure to document process changes and revalidation (21 CFR 820.75(c)), and failure to establish procedures for identifying valid statistical techniques for process and product characteristics (21 CFR 820.250(a)). Additionally, the firm failed to conduct periodic equipment maintenance inspections (21 CFR 820.70(g)(2)) and establish maintenance schedules for equipment (21 CFR 820.70(g)(1)). The FDA noted two repeat violations from a 2010 inspection concerning non-conforming product and process validation. The firm's responses were deemed inadequate. Teleflex must promptly correct these violations and provide a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, impact on federal contracts, and denial of premarket approvals or Certificates to Foreign Governments. A follow-up inspection will be conducted.