FDA WARNING_LETTER - WISSNER-BOSSERHOFF GMBH - April 25, 2024

An FDA inspection of Hauptstraβe 4-6, Wickede (Ruhr), Germany, from April 22-25, 2024, revealed that the firm's nursing beds, including the Sentida SC Nursing Bed, and SafeControl handset devices are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with the Quality System regulation (21 CFR Part 820), and the SafeControl handset devices are misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information under 21 CFR Part 806.

Key Quality System violations include failures in equipment suitability (21 CFR 820.72(a)), corrective and preventive action procedures (21 CFR 820.100(a)), supplier requirements (21 CFR 820.50(a)), design output procedures (21 CFR 820.30(d)), incoming product acceptance (21 CFR 820.80(b)), document control (21 CFR 820.40), and device history records (21 CFR 820.184). Additionally, the firm failed to record a correction or removal for the SafeControl handset issue, which FDA deemed a reportable event (21 CFR Part 806.20(b)(4)).

The firm's response dated May 15, 2024, was deemed inadequate for all violations, lacking sufficient evidence or comprehensive corrective actions. The FDA requires a written response within fifteen business days detailing specific steps, preventive measures, and a timetable for completion. Non-compliance may impact federal contracts and Class III device premarket approvals.