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

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.