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Every company manufacturing, importing, or distributing FDA-regulated products must be prepared for inspections and audits. Whether you operate in food, beverages, dietary supplements, cosmetics, or medical devices, an FDA inspection can happen at any time. Being unprepared may result in Form 483 observations, warning letters, import holds, or even suspension [...]
For companies that manufacture, package, or distribute FDA-regulated products, inspection and audit readiness is critical to maintaining compliance and avoiding enforcement actions. The FDA routinely conducts inspections, including at foreign facilities exporting to the U.S., to ensure adherence to regulatory standards. Lack of preparedness can result in Warning Letters, Import [...]
For FDA-regulated industries such as food, cosmetics, dietary supplements, and pharmaceuticals, preparing for an FDA inspection is essential to ensure uninterrupted market access. Inspections are designed to verify compliance with U.S. Food and Drug Administration (FDA) regulations, including cGMP (Current Good Manufacturing Practice), labeling requirements, and safety standards. Companies that [...]
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 [...]