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FDA compliance does not end after a product receives clearance or approval. Companies must actively manage post-market surveillance to ensure ongoing safety, effectiveness, and regulatory compliance. Failure to meet post-market obligations can lead to recalls, penalties, import alerts, and reputational damage. At XPRO AMERICA, we provide comprehensive post-market surveillance and [...]
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 [...]