# FDA 483 - Light Age, Inc. - September 29, 2023

Source: https://www.keypedia.com/records/483/light-age-inc/17fb52c2-1956-4c8b-85e2-ebbd8e571c6b

> FDA 483 for Light Age, Inc. on September 29, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Light Age, Inc.
- Inspection Date: 2023-09-29
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Light Age, Inc. in Somerset, NJ, was inspected from August 31 to September 29, 2023, revealing significant deficiencies across its quality system. The inspection found inadequate procedures for controlling nonconforming products, handling complaints, maintaining device master records, and managing calibration. Furthermore, the firm failed to establish proper corrective and preventive actions, conduct management reviews, control documents, and demonstrate design control for its Q-Clear device.

## 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 - 2022-07-01](https://www.keypedia.com/records/483/light-age-inc/295a1848-15dd-4659-b73d-098c064083fb)

## 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