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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 [...]
Ensuring FDA import compliance is essential for foreign medical device manufacturers and U.S. importers to avoid detention, refusal, or penalties at U.S. ports. The FDA enforces strict regulations on medical devices entering the U.S., including establishment registration, device listing, labeling, and prior notice requirements. At XPRO AMERICA, we provide comprehensive [...]
Importing Active Pharmaceutical Ingredients (APIs) and finished drug products into the United States requires strict compliance with U.S. Food and Drug Administration (FDA) and U.S. Customs & Border Protection (CBP) regulations. Any gaps in registration, labeling, or documentation can result in detention, refusal, or costly delays at U.S. ports of [...]
Successfully importing food, beverages, dietary supplements, cosmetics, and OTC products into the U.S. requires strict adherence to FDA import compliance and U.S. Customs clearance regulations. Failure to meet these requirements can result in costly delays, product detentions, or even refusals at the port of entry. The FDA, in coordination with [...]
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 [...]