FDA 483 - Caretaker Medical, Inc. - November 03, 2021

Caretaker Medical, LLC, a manufacturer and specification developer in Charlottesville, VA, was inspected from October 19 to November 3, 2021. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for design changes, corrective and preventive actions, complaint handling, and purchasing controls. These issues indicate a systemic failure to maintain proper documentation and follow established quality processes.