FDA 483 - I.V. Specialty, Ltd - July 17, 2014

This FDA Form 483 documents observations from an inspection of a facility manufacturing sterile drug products, specifically pediatric and adult Total Parenteral Nutrition (TPN). The inspection revealed numerous deficiencies in aseptic processing, environmental controls, and quality systems.

Key violations include: - **Personnel Garb:** Sterile garb was not consistently worn during aseptic processing in ISO 5 laminar airflow (LAF) hoods. Hair, ears, and forehead were exposed, and facemasks were improperly worn. - **Aseptic Processing Validation:** Procedures lacked adequate validation. Vials blocked unidirectional airflow, LAF hoods had spill guards potentially disrupting airflow, and media fills did not accurately simulate the production process, including infusion methods and transfer of solutions. - **Media Quality Control:** Growth promotion of media was not conducted, certificates of analysis were often absent, and positive/negative controls with traceability were not performed. Media fill bags were not incubated at USP recommended temperatures (20-25°C and 30-35°C). - **Environmental Monitoring:** Personnel monitoring was not conducted upon exiting the cleanroom. Environmental monitoring was not performed during each processing of sterile products, and alert/action limits were not established. Incubation temperatures for monitoring samples were incorrect, and documentation of incubation times/dates was lacking. - **Aseptic Equipment Maintenance:** No smoke studies were conducted under dynamic conditions for ISO 5 LAF hoods. Pressure differential monitoring was not conducted during production, nor was