In what can only be described as the regulatory equivalent of “We were in the neighborhood…”, the U.S. Food and Drug Administration (FDA) announced May 6, 2025, its expanded use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients. Yes, you read that correctly. Foreign facilities—once relatively shielded by time zone differences, diplomatic courtesy, and the occasional polite email—are now fair game for the FDA’s version of a pop quiz.
FDA advises that this change builds upon the Agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China, and seeks to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.
FDA’s new Commissioner, Dr. Martin A. Markary, stated, “For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track.”
While FDA conducts approximately 12,000 domestic inspections, it only conducts about 3,000 foreign inspections each year in more than 90 countries. The Agency stated that foreign facilities have unfairly had the opportunity to have weeks to prepare for an FDA inspection, compared to U.S. manufacturers who undergo frequent, unannounced inspections, jeopardizing the integrity of the oversight process. Alongside this announcement, FDA has advised that it will evaluate the agency’s policies and practices for improvements to the foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight. This includes changes and clarifying policies for FDA investigators to refuse travel accommodation from regulated industry (e.g. lodging and transportation arrangements) to preserve process integrity.
FDA further emphasizes that unannounced inspections aim to expose bad actors, including those who falsify records or conceal violations, before they can put American lives at risk. The Agency stated, “With this shift, the FDA is further ensuring that every product entering the U.S. is safe, legitimate, and honestly made.” The Agency reminds regulated industry that it is authorized to take regulatory action against any firm that seeks to delay, deny or limit an inspection, or refuses to permit entry for an unannounced inspection.
Legal Authority for Unannounced Inspections
The FDA’s authority to conduct inspections stems from the Federal Food, Drug, and Cosmetic Act (FDCA), specifically Section 704(a)(1), which grants the agency the power to inspect facilities involved in the manufacture, processing, packing or holding of FDA-regulated goods. While the FDA has historically provided advance notice for foreign inspections to accommodate logistical challenges, the new announcement directs the agency to conduct unannounced inspections of overseas facilities, again aligning with its domestic oversight practices.
Preventing Panic Attacks, One SOP at a Time
Let’s face it: in the regulated world, “winging it” isn’t a strategy—it’s a shortcut to a 483 and a very tense board meeting. If the phrase “strategic compliance requirements” sends a wave of panic, you’re not alone—but ignoring them is about as wise as storing raw materials next to cleaning supplies. To survive (and thrive) under the FDA’s ever-watchful gaze, companies need more than just good intentions and a half-written SOP. With less inspection lead times on the horizon, it’s time to turn compliance from a last-minute scramble into a well-rehearsed opera with the following strategies:
- Adopt the “Always Be Audit-Ready” Mindset: with FDA’s announcement, inspection readiness must become continuous.
- Ensure ongoing compliance with relevant Good Manufacturing Practices (GMPs).
- Maintain complete and contemporaneous documentation (the FDA does not like scavenger hunts!)
- Train staff to handle inspections without prior notice including practicing mock unannounced inspections and understanding “do’s and don’ts,” with legal and regulatory counsel.
- No English? No excuse. If your facility is a non-English speaking country, have interpreters on speed dial.
- Don’t Lie, Don’t Hide, Don’t Panic: this is the key to FDA survival. If something’s wrong, own it, document it, and show a plan to fix it. Cover-ups are like glitter: they always come back to haunt you, and they make everything worse!
- Monitor Regulatory Developments: regularly review FDA guidance documents, policy updates, and enforcement actions to remain aware of evolving regulatory requirements. Also, be prepared to adjust compliance strategies in response to new regulations or enforcement trends.
- Consult legal counsel to ensure that all strategies align with current regulations and best practices.
When the Clipboard Bites Back: Potential Enforcement Risks
From a regulatory standpoint, facilities that obstruct access or fail to provide records during an unannounced visit may be subject to import alerts, Form 483 observations, warning letters, injunction actions, or refusal of admission of products into the U.S. under Section 801(a) of the FDCA (in layman terms this means that your product cannot enter the US market). And don’t forget the public relations bonus: your compliance hiccup could end up on the FDA’s website for all your competitors—and customers—to see. In the world of enforcement, there are no participation trophies—just consequences, and they tend to come with a serious impact on your bottom line.
A Final Note on Strategic Readiness: From Risk to Resilience
The FDA’s expanded use of unannounced inspections at foreign manufacturing facilities reflects a strategic shift toward proactive, real-time regulatory oversight of the global supply chain. This approach raises the compliance stakes for regulated entities, demanding a new level of operational discipline and legal preparedness. Companies that invest in inspection readiness, staff training, document control, and global coordination will be best positioned to navigate this new regulatory landscape. With the support of legal and compliance teams, facilities can transform inspection preparedness from a periodic checklist into a core operational mindset.
For more information on FDA inspection preparedness, mock audits or other regulatory compliance and enforcement questions, please contact info@garg-law.com.
