# FDA 483 - The See Clear Company - November 22, 2019

Source: https://www.keypedia.com/records/483/the-see-clear-company/2a1b1ae7-c4bf-4b91-ae52-96e138b07d9e

> FDA 483 for The See Clear Company on November 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The See Clear Company
- Inspection Date: 2019-11-22
- Product Type: device
- Office Name: Atlanta District Office
- Summary: The Lee Clear Company, a specification developer of contact lenses in Peachtree Corners, GA, was cited for significant quality system deficiencies. The inspection revealed issues with design control, including deviations from the 510K and contract manufacturer's design, inadequate control over suppliers, and undocumented corrective actions. Additionally, the firm lacked adequate procedures for complaint handling and medical device reporting, and failed to document quality audits and personnel training, with the latter two being repeated observations.

## Related Documents

- [483 - 2022-05-24](https://www.keypedia.com/records/483/the-see-clear-company/45826dd5-ac2b-4771-9ccf-3191fa884f19)

## Related Officers

- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)
- [investigator](https://www.keypedia.com/people/sayeeda-hdabe/eaadc7cf-5f22-47c2-ba02-437efe0a5267)

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