California Pharmacy & Compounding Center – FDA 483, Aug 25, 2014

The FDA inspected California Pharmacy & Compounding Center, a 503B Outsourcing Facility in Newport Beach, CA, from August 18-25, 2014. The inspection revealed 15 observations related to deficiencies in facilities, equipment, quality systems, manufacturing, and labeling of sterile drug products.

Key violations include: - **Environmental Monitoring:** Failure to conduct daily environmental monitoring of air, personnel, and surfaces in ISO 7 and ISO 5 areas, and lack of monitoring personnel and environmental bio-burden during production. - **Contamination Control:** Deficiencies in preventing contamination, such as improper storage and reuse of sterilized stoppers, lack of closure container integrity testing, and a deficient cleanroom design with unclassified air exhaust vents, obstructed airflow, and no pressure differential monitoring. - **Cleaning and Disinfection:** Inadequate frequency of cleanroom cleaning and disinfection, and lack of sporicidal cleaning agents for ISO 5 environments. - **Equipment Qualification:** Absence of equipment qualification for sterilization and depyrogenation equipment, and no validation of sterilization methods for glass vials and rubber stoppers. - **Personnel Gowning:** Inadequate gowning practices, including the use of non-sterile face masks, hair nets, and shoe covers, exposed street scrubs, lack of sterile goggles, facial skin exposure, and employees bringing personal electronic devices into aseptic areas. - **Investigation of Discrepancies:** Failure to document investigations into