Surprise, Surprise: FDA Announces Plans to Increase Number of Unannounced Inspections at Foreign Manufacturing Facilities

In their song, “Surprise, Surprise,” the Rolling Stones lamented about being caught off guard by a disappointing relationship. Sixty years later, foreign manufacturers may face the surprise of an unannounced inspection by the Food and Drug Administration.

On May 6, 2025, FDA issued a press release announcing its intent to expand the use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products intended for American consumers and patients.”¹ This initiative builds on FDA’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China. It aims to ensure that foreign manufacturers receive the same level of regulatory scrutiny as domestic manufacturers.

Highlights

• FDA conducts approximately 12,000 domestic inspections each year but only 3,000 foreign inspections, which are spread across more than 90 countries.
• FDA intends to expand the use of unannounced inspections in an effort to put foreign and domestic manufacturers on a more level playing field and ensure that products are safe and effective when they enter the U.S. marketplace.

AGG Observations

Questions remain as to how FDA will implement its initiative to expand the use of unannounced inspections of foreign manufacturers.

• FDA has a long history of inspecting foreign firms, but has historically chosen to give advance notice, despite facing some criticism for doing so.² In support of this practice, FDA has previously explained that advance notice helps foreign manufacturers ensure that they have appropriate personnel present and requested documentation on hand when FDA inspectors arrive onsite.³ If FDA stops providing advance notice, foreign manufacturers may not have all requested documentation ready during an inspection, which could result in an increased incidence of failed inspections. While some inspections could, and should, fail due to non-compliance with significant quality-related issues, showing up unannounced when a company might be closed for a holiday appears to be a waste of time and may punish a company unnecessarily.
• From a practical standpoint, FDA’s recent staffing shortages will not help. If the agency does follow through on this objective, the resource expenditure may come at the cost of fewer domestic inspections or other commercial or license-related activities within the agency.
• Historically, FDA has often reserved surprise foreign inspection efforts for suspected “bad actors.” It is unclear whether FDA will issue additional guidance on where the agency will focus its attention with this new initiative or how foreign inspections will be conducted going forward.

As FDA’s shift to surprise foreign inspections unfolds, firms should ensure that their manufacturing sites are inspection-ready and that their personnel are trained on how to respond appropriately when inspectors arrive onsite. Otherwise, to quote the Rolling Stones again, firms may be in for a “surprise, surprise” upon receiving notice of a failed inspection.

[1] FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities, FDA (May 6, 2025) available here.

[2] 21 U.S.C. 321(b)(1), 384; See, e.g., Food Safety: FDA Should Strengthen Inspection Efforts to Protect the U.S. Food Supply, U.S. Government Accountability Office (Jan. 8, 2025) available here.

[3] Refusal of Inspection by a Foreign Food Establishment or Foreign Government: Guidance for Industry, FDA (October 2022) available here.