# FDA 483 - Visionary Contact Lens, Inc. - November 10, 2021

Source: https://www.globalkeysolutions.net/records/483/visionary-contact-lens-inc/a2038f9c-ddc9-4bd7-85ac-bbaf324f100c

> FDA 483 for Visionary Contact Lens, Inc. on November 10, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Visionary Contact Lens, Inc.
- Inspection Date: 2021-11-10
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Visionary Contact Lens, Inc. in Anaheim, CA, a manufacturer of gas permeable contact lenses, was cited for significant quality system deficiencies during an FDA inspection. Observations included a lack of defined supplier control procedures, inadequate documentation of corrective and preventive action effectiveness plans, and undocumented process validation activities. The lack of documented process validation was noted as a repeat observation.

## Related Officers

- [Kevin N. Tran](https://www.globalkeysolutions.net/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.globalkeysolutions.net/companies/visionary-contact-lens-inc/b4813872-6ade-42df-88eb-e0b2058d5880

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6