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

Source: https://www.keypedia.com/records/483/vision-science-co-ltd/d76a6b3c-2f9f-4d39-b56e-061dfe57e722

> FDA 483 for Vision Science Co., Ltd. on February 13, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vision Science Co., Ltd.
- Inspection Date: 2020-02-13
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - 2023-11-16](https://www.keypedia.com/records/483/vision-science-co-ltd/7437f968-6843-43d3-9458-cf373482973b)

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/vision-science-co-ltd/d62f49e7-4c43-4f3a-a3f9-4edcecf0fa9b

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd