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Viwit Pharmaceuticals' Sterile Production Facility Successfully Passes U.S. FDA Inspection
Author：
VIWIT
Release Time：
2025-06-11
From March 31 to April 8, 2025, the U.S. Food and Drug Administration (FDA) conducted a rigorous seven-day inspection at Viwit Pharmaceuticals Co., Ltd.'s sterile production facility. The FDA investigators thoroughly evaluated the company's six key systems: Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System.
Viwit Pharmaceuticals has received official notification and the Establishment Inspection Report (EIR) from the U.S. FDA, confirming full compliance with current Good Manufacturing Practice (cGMP) requirements. The inspection outcome was classified as Voluntary Action Indicated (VAI), confirming the successful inspection result.
This achievement demonstrates that Viwit's quality management system meets international standards, enabling the company's sterile products—including small-volume injectables, lyophilized products, and BFS eye drops—to enter the U.S. market. It also strengthens Viwit's strategic position for further expansion into international markets.
Viwit Pharmaceuticals maintains an unwavering commitment to its "Quality First" principle. The successful FDA inspection not only validates the company's quality standards but also marks a new phase in its global development. The company will continue to enhance its cGMP compliance, advance technological innovation, and accelerate global product registrations.
Looking ahead, Viwit Pharmaceuticals will leverage this milestone to further advance its sterile manufacturing capabilities. The company remains dedicated to providing safe, effective, and high-quality medicines to patients worldwide, contributing to global health through continuous innovation and quality excellence.
