# FDA 483 - Light Age, Inc. - July 01, 2022

Source: https://www.keypedia.com/records/483/light-age-inc/295a1848-15dd-4659-b73d-098c064083fb

> FDA 483 for Light Age, Inc. on July 01, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Light Age, Inc.
- Inspection Date: 2022-07-01
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Light Age, Inc. received a Form 483 with 17 observations related to its Q-Clear device, indicating significant deficiencies across its quality management system. Issues include inadequate device master and history records, lack of proper process controls, and failures in equipment calibration, corrective actions, and complaint handling. These findings highlight a systemic non-compliance with medical device regulations, particularly 21 CFR 820.

## Related Documents

- [WARNING_LETTER - 2017-11-17](https://www.keypedia.com/records/warning_letter/light-age-inc/1068ad33-35e7-45b6-999a-66c793627582)
- [483 - 2020-03-11](https://www.keypedia.com/records/483/light-age-inc/ca858b3f-7223-4076-ae88-20ed6025245b)
- [483 - 2023-09-29](https://www.keypedia.com/records/483/light-age-inc/17fb52c2-1956-4c8b-85e2-ebbd8e571c6b)

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/light-age-inc/2b122b60-50bd-4ad9-859f-9cd6214ac6c9

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248