FDA WARNING_LETTER - Eurotrol B. V. - May 22, 2014

The FDA issued a Warning Letter to Eurotrol B.V. following an inspection from May 19-22, 2014, in Ede, Netherlands. The inspection revealed that the firm's Class II Hematocrit Controls and Reference Materials are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act, as manufacturing methods and controls do not conform to the Quality System regulation (21 CFR Part 820). Key violations include: 1) Failure to establish and maintain procedures for validating device design (21 CFR 820.30(g)), specifically regarding stability studies for multiple products. 2) Failure to adequately validate processes where results cannot be fully verified by subsequent inspection and test (21 CFR 820.75(a)), such as cleaning processes and revalidation of equipment. 3) Failure to establish and maintain procedures to control nonconforming product (21 CFR 820.90(a)), evidenced by uninitiated nonconforming reports and undocumented disposals. 4) Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a)), lacking timely processing requirements. 5) Failure to establish and maintain procedures to control all required documents (21 CFR 820.40), specifically not updating procedures after database changes. The FDA deemed the firm's June 12, 2014, response inadequate for all observations, citing insufficient evidence of implemented corrections, retrospective reviews, and systemic corrective actions. Eurotrol B.V. must provide a written response within fifteen business days detailing specific corrections, preventative measures, and a timetable for completion, with potential implications for federal contracts and device approvals.