FDA 483 - Medefil Incorporated - April 21, 2025

Medefil, Inc., a sterile drug manufacturer in Glendale Heights, IL, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into unknown impurities in drug products, insufficient controls over computerized systems for production data, and failures in equipment cleaning and laboratory procedure adherence. These issues indicate a lack of robust quality control and sanitation practices that could impact product safety and purity.