FDA 483 - Lonza Bend Inc. - May 24, 2023

An FDA inspection of Lonza Bend Inc., a contract drug manufacturer in Bend, OR, revealed significant deficiencies across its quality system. Observations included inadequate controls over computerized systems and data integrity, issues with equipment design and qualification, and a critical failure in component identity testing for drug products, specifically regarding toxic glycol derivatives in pediatric formulations. These findings indicate a high severity of non-compliance impacting product quality and patient safety.