FDA 483 - Vital Care Compounder, Inc - October 13, 2022

This FDA Form 483 document details observations from an inspection, indicating significant deficiencies in aseptic processing and quality control. The facility failed to adequately evaluate product and take remedial action for actionable microbial contamination in the ISO 5 classified aseptic processing area during production. Sterilization cycle parameters for sterile products were not lethal to heat-resistant microorganisms, and final containers/closures for sterile drug products were not sterilized.

The ISO 5 classified aseptic processing areas exhibited difficult-to-clean, particle-generating, and visibly dirty equipment or surfaces. Disinfecting agents, cleaning pads, and cleaning wipes used in these areas were not sterile. Personnel used non-sterile tools and manually contacted the inner surface of containers or closures, and did not disinfect and change gloves frequently enough.

The facility produced hazardous drugs without adequate segregation, cleaning of work surfaces, and cleaning of utensils to prevent cross-contamination. Media fills did not closely simulate aseptic production operations, failing to incorporate worst-case activities and conditions. Furthermore, ISO 5 classified areas were not adequately certified under dynamic conditions. These observations indicate critical deficiencies in the facility's quality system, manufacturing processes, and environmental controls for sterile and hazardous drug production.