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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 [...]
For companies regulated by the U.S. Food and Drug Administration (FDA), compliance is not a one-time process but an ongoing responsibility. Each year, manufacturers, distributors, importers, and other regulated entities must renew their establishment registration and update product listings to remain in good standing with the FDA. In addition, regulatory [...]
For companies manufacturing, repacking, relabeling, or distributing human and veterinary drugs, annual and ongoing compliance with the U.S. Food and Drug Administration (FDA) is a mandatory responsibility. Non-compliance can lead to penalties, product recalls, import alerts, and loss of market access in the United States. XPRO America specializes in providing [...]