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FDA Inspection & Audit Readiness Post-510(k) – XPRO AMERICA

After obtaining 510(k) clearance, medical device manufacturers must maintain strict compliance with the FDA Quality System Regulation (QSR, 21 CFR Part 820). FDA inspections can occur at any time and focus on ensuring that your quality management system, production processes, and corrective actions meet regulatory requirements. Being unprepared can result [...]

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Dietary Supplements & Nutraceuticals Compliance Services – XPRO AMERICA

The dietary supplements and nutraceuticals industry in the U.S. is highly regulated under 21 CFR Part 111 to ensure product safety, quality, and accurate labeling. Compliance with FDA regulations is mandatory for manufacturers, distributors, and importers, covering facility registration, labeling, Good Manufacturing Practices (GMP), and reporting new dietary ingredients (NDIs). [...]

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