FDA 483 - Permobil Inc - January 11, 2018

An FDA inspection of Permobil Inc. in Lebanon, TN, a manufacturer, revealed two significant observations. The firm failed to adequately establish and implement procedures for corrective and preventive actions, including delays in opening CAPAs and improper approvals. Additionally, procedures for controlling non-conforming products were found to be inadequate, with issues in investigation, documentation of disposition, and rework activities.