Search for:
  • Home/
    • Tag: FDA corrective actions

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 [...]

Tags:
Read More

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 [...]

Tags:
Read More