FDA 483 - Steri-Med Pharma Inc. - February 27, 2024

Steri-Med Pharma Inc., a sterile manufacturer, was subject to an FDA inspection from February 19 to 27, 2024. The inspection concluded with the issuance of an FDA Form 483, highlighting significant observations regarding deficiencies in the aseptic processing areas' air supply, which is critical for ensuring product sterility.

The primary observation indicated that the facility's aseptic processing areas lacked sufficient air supply filtered through high-efficiency particulate air filters under positive pressure. Specifically, airflow visualization studies for an ointment filling line demonstrated turbulent and eddying smoke patterns, suggesting inadequate airflow at crucial aseptic filling points during both interventions and normal operations.

Additionally, the FDA noted the absence of essential studies, such as smoke studies, non-viable particulate monitoring, or settling plates, to evaluate the impact of a storage cart used for packaging materials within the controlled environments. This cart, situated near the Grade A filling line and over an air return, had not been shown to maintain airflow integrity in these critical areas.

These observations point to concerns about the environmental control necessary for sterile manufacturing. Steri-Med Pharma Inc. is expected to respond to these findings by either discussing any objections or outlining comprehensive corrective actions to address the identified deficiencies and ensure adherence to regulatory standards for sterile drug production.