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Viwit Solid-Dosage Manufacturing Site Successfully Completes Another U.S. FDA cGMP Inspection
Author：
VIWIT
Release Time：
2026-08-10
From June 15 to 18, 2026, the U.S. Food and Drug Administration (FDA) conducted a four-day on-site inspection of Viwit’s solid-dosage manufacturing facility. The inspection covered six core systems: quality management, facilities and equipment, materials, production, packaging and labeling, and laboratory controls. FDA investigators conducted a comprehensive review of the site’s manufacturing and quality systems.
Viwit recently received the FDA’s Establishment Inspection Report (EIR). The inspection was classified as VAI (Voluntary Action Indicated), confirming completion of the FDA cGMP inspection process for the solid-dosage manufacturing site.
This was the first FDA cGMP inspection of the site following commercialization of its solid-dosage products. Completion of the inspection further demonstrates the maturity of Viwit’s commercial manufacturing platform and represents another step in the company’s global development. Viwit will continue strengthening its cGMP quality management system and upholding its core principle of customer focus and quality first, supported by reliable manufacturing and continuous innovation to provide safe, effective, and consistently high-quality medicines for patients worldwide.
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