Enhancing Readiness for FDA’s Expanded Foreign Inspection Program

Earlier this year, the FDA announced an expansion of its unannounced inspection program targeting foreign manufacturing facilities that supply pharmaceutical products and medical devices. This increased scrutiny follows a U.S. Presidential Executive Order aimed at strengthening domestic pharmaceutical production and directing the FDA to enhance oversight of foreign sites. The intent is to create parity between domestic and foreign Good Manufacturing Practice (GMP) inspections, with a focus on product quality, supply chain integrity, and regulatory accountability.

What does this mean for U.S. sponsors and product developers utilizing foreign manufacturing sites? Here are four practical steps to prepare for this shift:

1. Map Your Manufacturing Footprint:
   Confirm where every critical raw material, critical starting material (cells, plasmids, etc.), drug substance, and drug product are being manufactured. This risk-based assessment enables targeted oversight and mitigation across your supply chain.
2. Strengthen Inspection Readiness Oversight:
   Establish a proactive and sustainable inspection readiness oversight program that reinforces data integrity, deviation and CAPA management, change control execution, and site-level ownership of quality systems.
3. Simulate Real-World Scenarios:
   Conduct mock inspections with a focus on key compliance risk areas: data integrity, cleaning validation, traceability, and batch record accuracy.
4. Extend a Culture of Quality Across the Supply Chain:

Prioritizing quality from the onset and embedding it into oversight practices ensures sustained compliance regardless of inspection timing.

Wondering How to Operationalize Inspection Readiness? 

 Halloran’s methodology is built to help life science companies anticipate, prepare, and succeed in today’s evolving regulatory environment. Contact Us to learn how we can support your team.