USHIO Europe B.V. – FDA Warning Letter, Aug 23, 2019

An FDA inspection conducted from August 19-23, 2019, at a firm in Bavaria, Germany, manufacturing UV lamps, identified significant violations of the Quality System (QS) regulation (21 CFR Part 820). The UV lamps are classified as medical devices, and the manufacturing methods render them adulterated under the Federal Food, Drug, and Cosmetic Act. The inspection revealed seven distinct deficiencies, including repeat observations for inadequate process validation (21 CFR 820.75(a)), insufficient control of nonconforming product (21 CFR 820.90(a)), and deficient corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)). Other violations included failure to validate computer software (21 CFR 820.70(i)), establish procedures for valid statistical techniques (21 CFR 820.250(b)), maintain in-process acceptance procedures (21 CFR 820.80(c)), and maintain Device History Records (DHRs) (21 CFR 820.184). The firm's August 26, 2019, response to the FDA 483 was deemed inadequate for all observations, lacking sufficient documented evidence of corrections or comprehensive retrospective reviews. The FDA requires the firm to provide a written response within fifteen business days detailing specific, systemic corrective actions, a prevention plan, supporting documentation, and a timetable. Failure to correct these violations may impact federal contracts, premarket approvals for Class III devices, and Certificates to Foreign Governments.