FDA WARNING_LETTER - Ulrich Gmbh & Co. KG - May 03, 2013

An FDA inspection of Ulrich GmbH & Co. KG in Ulm, Germany, from April 29 to May 3, 2013, revealed that their Pezo PEEK Cage System devices are adulterated and misbranded. The devices were found adulterated under section 501(h) of the Act because manufacturing methods and controls did not conform to the Quality System (QS) regulation (21 CFR Part 820). Specific QS violations included failures to establish and maintain procedures for corrective and preventive action (21 CFR 820.100(a)), design control (21 CFR 820.30(a)), supplier control (21 CFR 820.50(a)(2)), and quality audits (21 CFR 820.22). The devices were also misbranded under section 502(t)(2) due to the firm's failure to adequately develop, maintain, and implement written Medical Device Reporting (MDR) procedures (21 CFR 803.17(a)). The firm's May 21, 2013, response was largely deemed inadequate, lacking sufficient evidence of comprehensive corrective actions, retrospective reviews, or employee training. As a result, the Pezo PEEK Cage System devices are subject to refusal of admission into the U.S. The FDA requires a written response within fifteen business days detailing specific corrections, preventive actions, supporting documentation, and a timetable for completion, with a potential re-inspection to verify compliance.