FDA 483 - Itc Compounding - July 23, 2019

An FDA inspection of Infusion Treatment Center Inc dba ITC Compounding in Castle Rock, CO, revealed significant deficiencies in their production of non-sterile drugs. The firm failed to prevent cross-contamination, maintain clean production environments, and ensure the quality of components. Furthermore, there was a complete absence of adequate laboratory controls, GMP training for staff, and written procedures for quality control and production processes, indicating a severe lack of oversight and control over drug manufacturing.