FDA 483 - Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy - February 20, 2020

An FDA inspection of Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy in Murrieta, CA, revealed significant deficiencies in their sterile and non-sterile drug production. Observations included visibly dirty aseptic processing areas, inadequate HEPA filter coverage, insufficient cleaning and disinfection, and the use of non-pharmaceutical grade components. The firm also failed to adequately monitor the environment and conduct appropriate media fills, raising concerns about product sterility and cross-contamination.