# FDA 483 - Expack Usa Inc - October 18, 2023

Source: https://www.keypedia.com/records/483/expack-usa-inc/eb739306-a628-4dcd-93d0-473de4258baa

> FDA 483 for Expack Usa Inc on October 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Expack Usa Inc
- Inspection Date: 2023-10-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Expack USA, Inc. was inspected and cited for significant deficiencies across its quality system, personnel training, and manufacturing controls. Observations included failures in supplier qualification, employee GMP training, equipment validation, cleaning validation, and temperature monitoring for drug product storage. These issues indicate a lack of adherence to good manufacturing practices that could impact drug product quality and purity.

## Related Officers

- [Suchan Kim](https://www.keypedia.com/people/suchan-kim/1acf9a36-036f-48a8-a8a4-caa290830e37)
- [Stephenie M. Ortiz](https://www.keypedia.com/people/stephenie-m-ortiz/b0923b14-b153-4893-8eb2-f5e6b1fd2041)
- [Director of Clinical Training](https://www.keypedia.com/people/helen-verdel/f6caf5a8-74f5-4833-bd00-5579b369f4f9)

Company: https://www.keypedia.com/companies/expack-usa-inc/aa8788e6-7e8b-4136-98b0-47b9d0621314

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