FDA 483 - Forcemech International LLC - April 16, 2021

Forcemech International LLC, a relabeler/repacker of power wheelchairs in Pearland, TX, received a Form FDA-483 with 11 observations. The inspection revealed severe deficiencies across its quality system, including inadequate procedures for MDR reporting, complaint handling, incoming product acceptance, corrective and preventive actions, rework, servicing, supplier control, nonconforming product, quality audits, management review, and employee training. Several observations were repeats from a previous inspection, indicating a persistent failure to establish and implement a compliant quality system.