FDA 483 - Steri-Pharma, LLC - August 08, 2025

Steri-Pharma, LLC in Syracuse, NY, was inspected and cited for significant deficiencies across three observations. The inspection revealed inadequate written procedures for production and process controls, particularly concerning process validation studies for drug products. Additionally, the firm failed to adequately validate its aseptic processes and did not thoroughly review unexplained discrepancies, including repeated mold recoveries in aseptic processing areas.