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Human Cells, Tissues, and Cellular/Tissue-Based Products (HCT/Ps) are highly regulated by the FDA to ensure safety, quality, and traceability. Facilities that manufacture, process, store, or distribute HCT/Ps must comply with 21 CFR Part 1271 requirements, including registration, listing, adherence to Good Tissue Practices (GTP), and inspection readiness. At XPRO AMERICA, [...]
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 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 [...]