# FDA 483 - Cosmed of New Jersey - April 24, 2026

Source: https://www.keypedia.com/records/483/cosmed-of-new-jersey/5dc777b9-ecd2-416e-b731-0d46ed903773

> FDA 483 for Cosmed of New Jersey on April 24, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmed of New Jersey
- Inspection Date: 2026-04-24
- Product Type: device
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Lynx Medical of NJ LLC in Franklin, NJ, a contract sterilizer of medical devices, revealed significant deficiencies in its quality system. The firm failed to adequately document and control nonconforming products, often bypassing formal evaluation and disposition processes. Additionally, its risk management procedures for product realization were found to be inadequately implemented, potentially compromising patient safety.

## Related Officers

- [Jaro P. Perera](https://www.keypedia.com/people/jaro-p-perera/5555676c-2151-4ecd-bad8-72a1ddab8936)
- [Monica L. Gutierrez](https://www.keypedia.com/people/monica-l-gutierrez/fe60f8c6-ad1b-4619-9903-ed7be6d3bf7d)

Company: https://www.keypedia.com/companies/cosmed-of-new-jersey/07989634-79db-4b4b-a130-2ef99c68ff47

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