# FDA 483 - Crystalvue Medical Corporation - May 14, 2026

Source: https://www.globalkeysolutions.net/records/483/crystalvue-medical-corporation/118fe01f-768e-4828-84fe-17eb82fa52b9

> FDA 483 for Crystalvue Medical Corporation on May 14, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Crystalvue Medical Corporation
- Inspection Date: 2026-05-14
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: 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.

## Related Officers

- [Nicholas C Mendiola](https://www.globalkeysolutions.net/people/nicholas-c-mendiola/387f053a-af5f-4da9-8042-031124b9467d)

Company: https://www.globalkeysolutions.net/companies/crystalvue-medical-corporation/1627bb06-ae19-4985-b8e1-08157b0d299f

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7