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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 GMP inspections, with a focus on product quality, supply chain integrity, and regulatory accountability.
What does this mean for US sponsors and product developers utilizing foreign manufacturing sites? Here are four practical steps to prepare for this shift:
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 sciences companies anticipate, prepare, and succeed in today’s evolving regulatory environment. Contact Us to learn how we can support your team.