# FDA 483 - The See Clear Company - May 24, 2022

Source: https://www.keypedia.com/records/483/the-see-clear-company/45826dd5-ac2b-4771-9ccf-3191fa884f19

> FDA 483 for The See Clear Company on May 24, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The See Clear Company
- Inspection Date: 2022-05-24
- Product Type: device
- Office Name: Atlanta District Office
- Summary: The See Clear Company, a specification developer of contact lens devices in Peachtree Corners, GA, received five observations during an FDA inspection. The firm was cited for significant deficiencies in its quality system, including a lack of established procedures for design transfer, quality audits, and management review. Additionally, inadequate documentation for CAPA activities and change records were noted, with some issues being repeat observations from prior inspections.

## Related Documents

- [483 - 2019-11-22](https://www.keypedia.com/records/483/the-see-clear-company/2a1b1ae7-c4bf-4b91-ae52-96e138b07d9e)

## Related Officers

- [Melanie W. Pishnery](https://www.keypedia.com/people/melanie-w-pishnery/ff4846b0-ffe1-4df0-9116-4bb238866b3a)

Company: https://www.keypedia.com/companies/the-see-clear-company/03b1cb38-f015-40d2-903e-6cc37bc7a9ba

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7