Caltag Medsystems Ltd – FDA 483, May 4, 2023

An FDA inspection of Caltag Medsystems Ltd, a medical device manufacturer in Buckingham, United Kingdom, revealed significant deficiencies in their quality system. Observations included inadequate design review, lack of established design transfer procedures, insufficient process validation, and poorly documented corrective and preventive actions. These issues indicate a need for improved adherence to quality system regulations.