FDA 483 - Vision Science Co., Ltd. - February 13, 2020

Vision Science Co., Ltd., a medical device manufacturer in Daegu, Korea, was cited for significant deficiencies across three observations during an FDA inspection. The firm failed to adequately validate manufacturing processes for soft contact lenses and blister packaging, did not properly establish or follow procedures for nonconforming product disposition, and had inadequate design review procedures lacking independent reviewer participation and proper planning. These issues indicate a lack of adherence to established quality system requirements.