ONY Biotech, Inc. – FDA 483, Feb 5, 2026

ONY Biotech, Inc., an API and sterile drug manufacturer in Amherst, NY, was cited for significant deficiencies in quality control and manufacturing processes. The inspection revealed failures to thoroughly investigate discrepancies and microbial excursions, inadequate procedures for preventing microbiological contamination of sterile products, and unauthorized changes to temperature monitoring without proper documentation. These issues indicate a lack of robust quality systems and control over critical manufacturing steps.