Unannounced FDA Inspections Without Borders

Unannounced FDA Inspections Without Borders Image

Unannounced FDA inspections are no longer limited to the U.S. — they’re expanding globally. Starting in 2025, foreign sites will face the same surprise visits and public scrutiny as U.S. facilities, raising the stakes for sponsors and manufacturers alike.

A single failed inspection can derail years of investment, delay patient access, and damage investor confidence. Readiness can’t be a one-time effort; it must be embedded in daily operations. ProPharma’s experts provide end-to-end support, gap analyses, SME training, mock inspections, and ongoing audits, so your quality systems are inspection-ready every day, not just on paper.

Learn how to safeguard your operations and stay compliant in an era of real-time FDA evaluations and worldwide regulatory pressure.

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