Crystalvue Medical Corporation – FDA 483, May 14, 2018

Crystalvue Medical Corporation in Taoyuan, Taiwan, received a Form 483 for inadequate design validation during an inspection of its medical device manufacturing facility. The firm failed to use initial production units or their equivalents for the Non-contact Tonometer (NCT) design validation. Additionally, design control procedures were found lacking in clearly defining the use of production units for validation activities.