FDA 483 - Lonza Biologics, Inc. - April 16, 2026

Lonza Biologics, Inc. in Portsmouth, NH, was inspected and received a Form 483 with three observations related to significant manufacturing and quality control deficiencies for their CASGEVY drug product. The inspection revealed a lack of process control over CASGEVY manufacturing, failures in preventing microbiological contamination of sterile products, and inadequate warehousing procedures for final drug product vials. These issues indicate a serious lack of adherence to good manufacturing practices.