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XPRO America – US FDA Drug Establishment Registration (21 CFR Part 207)

The US FDA Drug Establishment Registration is a mandatory requirement under 21 CFR Part 207 for all facilities engaged in the manufacturing, repacking, relabeling, or distribution of human and veterinary drugs intended for the U.S. market. This regulation applies to both domestic and foreign facilities, ensuring that all establishments involved [...]

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XPRO America – FDA Annual & Ongoing Compliance Services for Drug Firms

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 [...]

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