Nemschoff Chairs, Inc. – FDA Warning Letter, May 4, 2011

On May 3-4, 2011, an FDA inspection of Nemschoff Chairs, Inc. in Sheboygan, Wisconsin, revealed that their bassinets, classified as medical devices, were adulterated and misbranded. The firm failed to conform to Quality System (QS) regulation (21 CFR Part 820) and Medical Device Reporting (MDR) regulation (21 CFR Part 803).

Key violations include: 1. **Failure to establish and maintain design control procedures (21 CFR 820.30(a))**: No design control procedure, design plan, or requirements for design inputs/outputs. The firm's 60-day proposed implementation was inadequate, lacking retrospective review, procedure copy, or training plan. 2. **Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a))**: No CAPA procedures. The firm's 30-day proposed implementation was inadequate, lacking retrospective review, procedure copy, or training plan. 3. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: No formal procedure for timely complaint review, documentation, or MDR evaluation. The firm's 30-day proposed implementation was inadequate, lacking retrospective review, procedure copy, or training plan. 4