FDA 483 - Forcemech International LLC - March 17, 2020

An FDA inspection of Forcemech International LLC, a repacker/relabeler of Class 2 power wheelchairs in Pearland, TX, revealed significant deficiencies across its quality system. The firm failed to adequately handle and investigate complaints, including major safety issues like wheelchair frames snapping and controller malfunctions. Additionally, the company lacked established procedures for incoming product acceptance, supplier evaluation, service report documentation, distribution records, and a fully implemented quality system.