FDA 483 - Marquis Energy - Illinois LLC - January 31, 2025

During an inspection by the FDA's Chicago District Office from January 27-31, 2025, Marquis Energy, LLC, an API Manufacturer in Hennepin, IL, received an FDA Form 483 citing several significant observations. The report, addressed to Andrew L. Rowe, Vice President of Operations, details deficiencies in the company's quality systems and manufacturing controls. Main violations included the quality unit's failure to ensure API Ethanol met established specifications, specifically by approving Certificates of Analysis (COAs) without reviewing critical production records. The firm also lacked established procedures and comprehensive master batch records for ensuring finished API quality, with significant manufacturing steps for API Ethanol not being properly documented. Furthermore, Marquis Energy had not implemented a process validation program to confirm the consistent quality of its API Ethanol production, nor an ongoing stability testing program for Purified Alcohol and API Ethanol to establish appropriate retest or expiry dates. Lastly, personnel within the Quality Assurance and Quality Control units were found to lack adequate training in ICHQ7 practices, impacting their ability to fulfill critical duties and provide training. These observations highlight areas where Marquis Energy must implement comprehensive corrective actions to ensure product quality, purity, and compliance with the Federal Food, Drug and Cosmetic Act.