FDA 483 - Max Mobility LLC - December 06, 2023

PERMOBIL, a Spec Developer in Lebanon, TN, was cited by the FDA for significant deficiencies in its quality system. The inspection revealed inadequate procedures for receiving, reviewing, and evaluating complaints, leading to customer feedback not being properly escalated into formal complaints. Furthermore, the firm lacked established procedures for corrective and preventive actions, with customer feedback not being adequately reviewed for potential quality issues impacting consumer safety.