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Foreign food, beverage, drug, cosmetic, or medical device companies that want to market their products in the United States must comply with U.S. Food and Drug Administration (FDA) regulations. One of the most critical requirements is the appointment of a U.S. Agent. The FDA mandates that all foreign facilities designate [...]
Achieving U.S. FDA compliance is only the first step maintaining it requires constant attention. FDA regulations are dynamic, with frequent updates to labeling rules, safety standards, registration requirements, and inspection protocols. Businesses that fail to keep up with these changes risk losing market access, facing enforcement actions, or damaging their [...]
XPRO America provides expert services for USFDA Agent Registration, a mandatory requirement for foreign facilities exporting FDA-regulated products to the United States. The process can be complex, involving compliance with FDA guidelines and timely submission of accurate details. Our team simplifies the process, acting as your reliable U.S. Agent to handle [...]