FDA 483 - RemedyRepack Inc. - April 14, 2025

RemedyRePack Inc., a drug repacker and relabeler in Indiana, PA, received seven observations during an FDA inspection from April 8-14, 2025. The firm was cited for significant deficiencies in its quality control and production processes, including a repeat observation regarding packaging process validation. Key issues include inadequate written procedures for critical operations, poor labeling controls, and failure to maintain equipment cleanliness and proper drug storage conditions.