# FDA 483 - Eugia US Manufacturing LLC - December 22, 2023

Source: https://www.keypedia.com/records/483/eugia-us-manufacturing-llc/b4c5710f-9221-4deb-b08c-7ad35c549b99

> FDA 483 for Eugia US Manufacturing LLC on December 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eugia US Manufacturing LLC
- Inspection Date: 2023-12-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Eugia US Manufacturing LLC in East Windsor, NJ, was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed a dysfunctional quality control unit, inadequate aseptic processing controls, and unsuitable facility conditions. Furthermore, the firm demonstrated poor computer system controls, uninvestigated product deterioration, and scientifically unsound laboratory testing practices.

## Related Documents

- [483 - 2023-12-22](https://www.keypedia.com/records/483/eugia-us-manufacturing-llc/94e443ed-bdfc-4502-af0c-ba7773fc35c0)

## Related Officers

- [Yoriann M. Cabrera Bartolomei](https://www.keypedia.com/people/yoriann-m-cabrera-bartolomei/3f827fbc-dcd1-4698-9bae-e0e93b900d08)
- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)
- [Ruben C. Quintana](https://www.keypedia.com/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)

Company: https://www.keypedia.com/companies/eugia-us-manufacturing-llc/030efff2-f3a3-458b-acb3-a46ca712f589

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