# FDA 483 - Marquis Energy - Illinois LLC - January 27, 2025

Source: https://www.globalkeysolutions.net/records/483/marquis-energy-illinois-llc/e34860f4-bceb-4c85-b7e0-827103d87948

> FDA 483 for Marquis Energy - Illinois LLC on January 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Marquis Energy - Illinois LLC
- Inspection Date: 2025-01-27
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Marquis Energy, LLC in Hennepin, IL, an API manufacturer, received a Form 483 with five observations during an inspection from January 27-31, 2025. The observations primarily concern significant deficiencies in their quality unit responsibilities, lack of established procedures for API manufacturing, absence of a process validation program, and an inadequate stability testing program for their API Ethanol and Purified Alcohol. Additionally, personnel in the quality unit were found to lack appropriate training in ICHQ7 practices.

## Related Officers

- [Michele L. Glendenning](https://www.globalkeysolutions.net/people/michele-l-glendenning/a3c23a43-634c-4140-807b-c17fbc03bb00)

Company: https://www.globalkeysolutions.net/companies/marquis-energy-illinois-llc/4989c2b1-c984-418a-a735-c615dfb6050c

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