# FDA WARNING_LETTER - The Standing Company - March 27, 2013

Source: https://www.globalkeysolutions.net/records/warning_letter/the-standing-company/b72c5993-670e-4bcb-9396-b022eab3daca

> FDA WARNING_LETTER for The Standing Company on March 27, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Standing Company
- Inspection Date: 2013-03-27
- Product Type: Devices
- Office Name: Detroit District Office
- Summary: On May 7, 2013, the FDA issued a Warning Letter to The Standing Company following an inspection from March 6-27, 2013. The inspection revealed that the firm's manual Superstand Stand-Up Wheelchair and half/full powered Powerstand Stand-Up Wheelchairs are adulterated under 21 U.S.C. 351(h) due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations include:
- **Complaint Procedures (21 CFR 820.198(a)):** Failure to establish and maintain adequate complaint procedures; 173 of 228 service log entries met the complaint definition but were not investigated per procedures.
- **Process Validation (21 CFR 820.75(a)):** Lack of a validated welding process, despite numerous welded parts and seven complaints of broken welds.
- **Purchasing Controls (21 CFR 820.50):** Inadequate supplier assessment forms for multiple suppliers, outdated approved vendor lists, failure to reevaluate suppliers (e.g., motor supplier with 14 complaints), and no agreements requiring supplier notification of product/service changes.
- **Design Changes (21 CFR 820.30(i)):** Failure

## Related Officers

- [Program Division Director](https://www.globalkeysolutions.net/people/art-o-czabaniuk/37f1e249-9ee6-4275-9c28-391d93659b85)
- [Catherine V. Quinlan](https://www.globalkeysolutions.net/people/catherine-v-quinlan/320d6ab0-b4b9-4dda-a1c9-ab1a55fe9fe6)

Company: https://www.globalkeysolutions.net/companies/the-standing-company/313d8723-ab60-4985-b509-a491abd740a5

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03