FDA 483 - Lonza Biologics, Inc. - May 03, 2026

The FDA inspected Lonza Biologics, Inc. in Hopkinton, MA, a manufacturer of drug substance, revealing significant deficiencies. The firm failed to adequately investigate out-of-specification results, ensure timely completion of investigations, and maintain proper quality control over materials and processes for Ontak and Increlex drug substances. Additionally, issues were noted with equipment maintenance, cleaning validation, and comprehensive employee training.