# FDA WARNING_LETTER - Nemschoff Chairs, Inc. - May 04, 2011

Source: https://www.keypedia.com/records/warning_letter/nemschoff-chairs-inc/35c56ba9-a3da-45ed-a047-721d94cad576

> FDA WARNING_LETTER for Nemschoff Chairs, Inc. on May 04, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Nemschoff Chairs, Inc.
- Inspection Date: 2011-05-04
- Product Type: Devices
- Office Name: Minneapolis District Office
- Summary: 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.
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## Related Officers

- [Gerald J. Berg](https://www.keypedia.com/people/gerald-j-berg/ebeb00b9-51c9-4bc4-b393-bfdb01862028)

Company: https://www.keypedia.com/companies/nemschoff-chairs-inc/a45b0496-4e27-4779-b250-15d8d6953aa0

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d