FDA 483 - Pharmacy Innovations - November 30, 2022

The FDA Form 483 details numerous deficiencies at a facility producing sterile drug products, including Prostaglandin E1, Papaverine/Phentolamine, Phenol Injection, Vitamin D3, Glycerin, Prednisolone, and Testosterone injectable.

Key observations include: - **Inadequate HEPA filter coverage and airflow:** Light pod areas in the ISO 5 laminar air flow workbench (LAFW) lack proper sealing, causing turbulent and non-unidirectional airflow. Prostaglandin E1 was prepared in areas without adequate ISO 5 HEPA coverage or unidirectional airflow. - **Damaged/Contaminated HEPA filters:** Rust-like and yellowing discoloration was observed on multiple HEPA filters in the ISO 5 LAFW and ISO 7 anteroom. - **Deficient Media Fill Program:** Media fills do not represent batch sizes or container types, and exclude equipment used in sterile drug product preparation (e.g., a pump for IV bag filling). - **Inadequate Smoke Studies:** Smoke studies lacked sufficient smoke, failed to illustrate unidirectional airflow, and did not reflect all operations. Airflow was observed bouncing back from the wall. - **Facility Design Flaws:** Doors between the non-hazardous sterile cleanroom and unclassified non-sterile laboratory were observed open simultaneously, allowing influx of poor quality air. - **Environmental Monitoring Deficiencies:** Environmental monitoring was not performed in aseptic processing areas. Personnel monitoring procedures were flawed,