Griffith Statement on FDA Expansion of Unannounced Inspections at Foreign Manufacturing Facilities

The U.S. Food and Drug Administration (FDA) recently announced the agency’s intent to expand unannounced inspections at foreign manufacturing facilities that produce foods, medicines and other medical products intended for American consumers and patients. In response to this announcement, U.S. Congressman Morgan Griffith (R-VA) released the following statement:

“Through my oversight work in the House Committee on Energy and Commerce, I outlined serious inadequacies with the FDA’s foreign drug inspection program. American patients and consumers deserve access to products that are safe and reliable. They should always be protected from products that are dangerous and harmful. As President Trump works to secure domestic manufacturing of products like pharmaceutical drugs, I welcome Commissioner Makary’s pledge to further evaluate the foreign drug inspection program and improve the quality and safety of products for American consumers.”

BACKGROUND

On May 6, the FDA issued a press release describing its intent to expand the use of these unannounced inspections.

Rep. Griffith introduced a bill that was signed into law in 2022, H.R. 7006 – the INSPECTIONS Act, that requires the FDA to consider the compliance history of establishments in the country or region in which the establishment is located as a factor in their risk-based inspections schedule.

In the 118th Congress, Rep. Griffith chaired the House Committee on Energy and Commerce Subcommittee on Oversight & Investigations.

Rep. Griffith chaired hearings on various issues, including but not limited to FDA’s foreign drug inspections program

Additionally, Rep. Griffith helped lead multiple letters to the FDA.

Rep. Griffith’s e-newsletter on this topic can be found here.

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