FDA 483 - Mericon Industries Inc. - February 14, 2025

Mericon Industries Inc. in Peoria, IL, received a Form 483 for significant deficiencies in their drug manufacturing operations. The inspection revealed critical issues including inadequate raw material testing, lack of proper quality control unit procedures, absence of final product testing for active ingredients, and incomplete batch production records. These findings indicate a systemic failure to ensure drug product quality, purity, and strength.