# FDA 483 - Light Age, Inc. - March 11, 2020

Source: https://www.keypedia.com/records/483/light-age-inc/ca858b3f-7223-4076-ae88-20ed6025245b

> FDA 483 for Light Age, Inc. on March 11, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Light Age, Inc.
- Inspection Date: 2020-03-11
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Eight Age, Inc. in Somerset, NJ, revealed significant deficiencies across its quality system, particularly in corrective and preventive actions, complaint handling, and management oversight. The firm failed to adequately establish and maintain procedures for critical quality processes, including internal audits, equipment calibration, and document control. These findings indicate a systemic lack of adherence to quality system requirements for this medical device manufacturer.

## Related Documents

- [WARNING_LETTER - 2017-11-17](https://www.keypedia.com/records/warning_letter/light-age-inc/1068ad33-35e7-45b6-999a-66c793627582)
- [483 - 2022-07-01](https://www.keypedia.com/records/483/light-age-inc/295a1848-15dd-4659-b73d-098c064083fb)
- [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