# Quadm Technologies, Llc – FDA 483, Jan 8, 2026

Source: https://www.keypedia.com/records/483/quadm-technologies-llc/76e44ea7-bd9a-4424-85b7-b6f502b7a99d

> FDA 483 for Quadm Technologies, Llc on January 08, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quadm Technologies, Llc
- Inspection Date: 2026-01-08
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Quadm Technologies, Llc in Hamilton, NJ, a medical device manufacturer, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in process validation for cleaning, passivation, and CNC milling, as well as inadequate procedures for controlling non-conforming products, monitoring process parameters, and equipment maintenance. These issues indicate a lack of robust quality system controls for critical manufacturing processes.

## Related Documents

- [483 - 2022-04-25](https://www.keypedia.com/records/483/quadm-technologies-llc/7d31674c-8bc6-4f6c-a14b-bb4655fc3f1e) — date: April 25, 2022

## Related Officers

- [Jaro P. Perera](https://www.keypedia.com/people/jaro-p-perera/5555676c-2151-4ecd-bad8-72a1ddab8936)

Company: https://www.keypedia.com/companies/quadm-technologies-llc/3ab50164-9b97-406b-a633-099ac4730c15

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