# FDA 483 - Xttrium Laboratories, Inc. - June 18, 2025

Source: https://www.keypedia.com/records/483/xttrium-laboratories-inc/c29d29eb-46f3-4104-a21c-2f5a99530b5a

> FDA 483 for Xttrium Laboratories, Inc. on June 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xttrium Laboratories, Inc.
- Inspection Date: 2025-06-18
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Xtrium Laboratories, Inc., an API and Finished Product Drug Manufacturer in Mount Prospect, IL, was cited for significant deficiencies across its quality control, data integrity, and record-keeping practices. The inspection revealed issues with unqualified equipment, undocumented analyses, inadequate computer system controls, and a failure to investigate discrepancies, all of which compromise the reliability and integrity of their analytical data and product quality. These findings indicate a systemic breakdown in adherence to established procedures and regulatory requirements.

## Related Documents

- [483 - 2024-03-08](https://www.keypedia.com/records/483/xttrium-laboratories-inc/aef0adf8-fc5d-4131-883a-adf3dab56932)

## Related Officers

- [Supreet K. Sran](https://www.keypedia.com/people/supreet-k-sran/1dab51f8-b483-4ccb-8b44-89fdc3b8100b)
- [Tyler M. Peterson](https://www.keypedia.com/people/tyler-m-peterson/207310ee-260c-4618-a515-9895a56e2ede)
- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)
- [Ramia Brzenjy](https://www.keypedia.com/people/ramia-brzenjy/b0e5e3b0-c295-4ec6-845a-95968824c16a)

Company: https://www.keypedia.com/companies/xttrium-laboratories-inc/30da7793-2a5c-4bf5-814c-05fc0921d353

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669