FDA 483 - Wacker Biotech B.V. - November 21, 2025

From November 17 to November 21, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of Wacker Biotech B.V., a drug substance manufacturer located in Amsterdam, Netherlands. The inspection, documented in an FDA Form 483, identified five major areas of concern regarding the facility"s compliance with safety and quality standards. Primary violations included the use of unsuitable sample containers for endotoxin testing, which could lead to false-negative results due to material interference. Additionally, the firm failed to ensure data integrity, as electronic records of failed equipment integrity tests were not reconciled or included in the final batch production records. Investigators also noted that laboratory procedures lacked specific timing requirements for testing biological indicators used in sterilization processes, and the firm failed to follow its own protocols for environmental monitoring during production. Finally, inadequate cleaning procedures allowed liquid to drip from recently cleaned equipment into controlled production areas, posing a risk of microbial contamination. This document was issued under the Federal Food, Drug, and Cosmetic Act to notify management of objectionable conditions. Wacker Biotech B.V. is expected to submit a formal response to the FDA detailing their corrective and preventive actions to address these deficiencies and ensure future compliance with international manufacturing standards.