FDA 483 - Integrated Commercialization Solutions LLC - May 15, 2025

Integrated Commercialization Solutions LLC, a drug labeler in Lockbourne, OH, was cited for failing to adequately sample and examine labeling and packaging materials upon receipt and before use. The inspection revealed deficiencies in their procedures and documentation for quality checks on labels, leading to the use of uninspected labels in drug product packaging. This indicates a significant lapse in quality control for critical drug product components.