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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 [...]
USFDA Registration Services @XPRO AMERICA – Simplifying Your Path to the U.S. Market If your business aims to export food, cosmetics, dietary supplements, or medical devices to the United States, obtaining a USFDA Establishment Registration is a mandatory step. This process ensures your facility is recognized by the U.S. Food and Drug Administration (FDA) and is compliant [...]