Date:
April 24, 2026
Content:
The U.S. Food and Drug Administration (FDA) has released a Form 483 report following an inspection of Lonza AG’s facilities in Switzerland. The document highlights regulatory observations regarding the company’s manufacturing processes.
The FDA’s Center for Drug Evaluation and Research (CDER) published this record on October 28, 2025, after investigators concluded their site visit. A Form 483 is typically issued when agency officials observe conditions that may violate federal safety and quality requirements during the production of pharmaceuticals.
While the specific details of the observations are held within the full inspection report, the issuance serves as a formal notice for the company to address potential compliance gaps. Lonza AG is required to provide a written response to the FDA detailing their planned corrective actions to ensure adherence to Current Good Manufacturing Practices (cGMP).
Source: FDA CDER FOIA Electronic Reading Room
Link:
http://www.fda.gov/drugs/cder-foia-electronic-reading-room/lonza-ag-10282025
Keywords:
FDA, Lonza AG, Form 483, Switzerland, Drug Manufacturing, Regulatory Compliance, CDER