FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities

On May 13, 2025, the US Food and Drug Administration (FDA) announced the formal expansion of the use of unannounced inspections at foreign manufacturing facilities that produce drugs and medical devices destined for the US market.

This measure is part of a more robust enforcement strategy, the aim of which is to strengthen verification of ongoing compliance with FDA regulatory requirements, even outside US territory.

What changes for manufacturers?

With this update, the FDA makes it clear that international inspections will not depend on prior notice, but can take place at any time. This approach applies to facilities located outside the US involved in the manufacture, processing, packaging or storage of regulated products, including:

• Medical devices;

• Medicines and active substances;

• Combination products.

The decision aims to ensure that all players in the supply chain maintain consistent quality and safety practices, regardless of geographical location.

Implications for manufacturers outside the US

Manufacturers who export to the United States must:

• Ensure that quality management systems and technical documentation are permanently updated and accessible;

• Promoting a culture of continuous compliance, based on the principles of Good Manufacturing Practices (GMP);

• Prepare local teams to deal with unexpected inspections, with clear and traceable processes;

• Review contracts with subcontractors and critical suppliers, ensuring that they are also prepared for unannounced audits.

Strategic context

The expansion of unannounced inspections stems from the experience gained by the FDA during the pandemic period, when there was a need for more agile and effective regulatory responses, especially with regard to the safety of imported products.

In addition, the FDA has been strengthening its international collaboration programs, which could lead to mutual recognition of inspections in some regions, but without giving up the possibility of its own inspections, whenever necessary.

Read the full article at the link: https://www.fda.gov/news-events/press-announcements/fda-announces-expanded-use-unannounced-inspections-foreign-manufacturing-facilities?utm_medium=email&utm_source=govdelivery