FDA 483 - Lonza Manufacturing LLC - September 29, 2025

An FDA inspection conducted at Lonza Manufacturing LLC, a drug substance manufacturer in Vacaville, CA, from September 23-29, 2025, revealed several significant observations related to Good Manufacturing Practices (GMP). The inspection findings highlight concerns in quality control, equipment integrity, and record-keeping.

One primary issue identified was the company's inconsistent and often inconclusive root cause investigations into endotoxin deviations. For example, two separate endotoxin deviations were attributed to "unidentified laboratory error," resulting in a lack of specific corrective and preventive actions (CAPAs) to prevent recurrence. This indicates a potential weakness in the firm's quality system for deviation management.

Furthermore, inspectors noted an unassessed "white chalk-like stain" observed within a bioreactor during maintenance, suggesting insufficient follow-up on critical equipment anomalies. A significant concern was also raised regarding document control, as vital GMP manufacturing records, including signed material pick lists and pre-performed yield calculations, were found in shred bins designated for destruction instead of being properly filed or maintained as official documentation, contravening established procedures. Lonza Manufacturing LLC is expected to respond to these observations with robust corrective actions to ensure compliance with regulatory standards.