483
Crystalvue Medical CorporationFDA 483 - Crystalvue Medical Corporation - May 14, 2026
Record Details
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.
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ID · 118fe01f-768e-4828-84fe-17eb82fa52b9