FDA mock audits – My Blog

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 [...]

HCT/P Regulatory Compliance & FDA Registration – XPRO AMERICA

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, [...]

FDA Cosmetic Inspection & Audit Readiness – 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 [...]