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

An FDA inspection of Steri-Med Pharma Inc., a sterile manufacturer in Upton, revealed significant deficiencies in aseptic processing areas. The firm's airflow visualization studies for its aseptic filling line were inadequate, showing turbulent and eddying smoke patterns. Additionally, there was a lack of proper studies and monitoring to ensure a storage cart did not disrupt airflow in critical Grade A and B areas.