Leveling the Global Playing Field FDA Expands Unannounced Foreign Inspections-Are you Ready?
New inspection model levels the global playing field for manufacturers of food, drugs, and medical products
In a significant move to enhance public health safety, the U.S. Food and Drug Administration (FDA) has announced plans to expand unannounced inspections at foreign manufacturing facilities producing food, essential medicines, and medical products for U.S. consumers. This expansion builds on the FDA’s Foreign Unannounced Inspection Pilot Program in India and China, with the goal of ensuring that foreign manufacturers face the same level of scrutiny as domestic companies.
FDA Commissioner Dr. Martin A. Makary emphasized the end of the double standard, where foreign manufacturers were given advanced notice for inspections while U.S. companies faced surprise visits. The new policy aims to restore fairness and strengthen the FDA’s oversight globally.
The FDA will also review and refine its inspection policies, including a ban on travel accommodations from regulated industries, to maintain the integrity of its oversight process. Unannounced inspections are critical to uncovering violations and preventing unsafe products from reaching U.S. consumers.
With this shift, the FDA underscores its commitment to keeping American families safe by ensuring that all products entering the U.S. are safe, legitimate, and honestly made. This expanded inspection program marks a new era in regulatory enforcement, focusing on stronger measures to protect public health.
For organizations, this means:
- Ensuring readiness for inspections at any time
- Maintaining records and practices that can withstand real-time scrutiny
When it comes to inspection readiness, ask yourself and your team:
What’s the one thing your company is doing exceptionally well that tells you you’re truly ready for an unannounced inspection?
If you want to discuss your situation, maybe we can provide you with some insight or we may be able to offer a few suggestions.
