FDA WARNING_LETTER - The Standing Company - March 27, 2013

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 - **Purchasing Controls (21 CFR 820.50):** Inadequate supplier assessment forms for multiple suppliers, outdated approved vendor lists, failure to reevaluate suppliers (e.g., motor supplier with 14 complaints), and no agreements requiring supplier notification of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