FDA 483 - Marlex Pharmaceuticals, Inc. - November 14, 2025

An FDA inspection of Marlex Pharmaceuticals, Inc. in New Castle, DE, a drug repacker and relabeler, identified two significant observations. The firm's procedures for cleaning and maintaining packaging equipment were found to be deficient, lacking sufficient detail and adequate cleaning validation. Additionally, drug products were not stored under appropriate temperature and humidity conditions due to inadequate monitoring in the warehouse.