Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy – FDA 483, Feb 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.
- Inspection date
- February 20, 2020
- Product type
- drugs
ID · 96c70997-6179-409e-a18b-73b375f0bc30
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.