FDA 483 - Forcemech International LLC - March 17, 2020
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Office
- Dallas District Office
- Person
ID · 47e49ed8-f041-4887-84b3-41c5e64f32ed