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FDA Presses Pause on Domestic and Foreign Inspections for all FDA-Regulated Products Due To COVID-19 Concerns

Client Alert | 2 min read | 03.20.20

In response to the recent COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) has temporarily paused all domestic and international on-site inspections not deemed “mission-critical.”

On Wednesday, March 18th, FDA Commissioner Stephen Hahn announced that the Agency would temporarily halt domestic inspections not deemed “mission-critical,” citing concerns for the health and well-being of its staff.  These are inspections the FDA conducts every few years based on a risk analysis. Instead, during this interim period, the Agency will evaluate alternative ways to conduct inspectional work to ensure the safety of the firm and the FDA staff such as evaluating records in lieu of conducting onsite inspections.  It is important to note that domestic for-cause inspections will proceed if considered “mission-critical.”

Similarly, on March 10th, the Agency announced that it would temporarily scale back foreign inspections, through April, not deemed “mission-critical.”  The FDA cited a number of factors including State Department travel advisories, CDC travel recommendations, and other guidance.  FDA stated that in the interim, it would employ additional tools to ensure the safety of imported products, including denying entry of unsafe products, physical inspection, product sampling at the border, and reviewing the manufacturer’s compliance history, among others.  As is the case with domestic inspections, inspections of foreign facilities deemed “mission critical” will continue on a case-by-case basis.

FDA encourages the industry to “own” safety and quality during this unprecedented time, and adhere to existing reporting and cGMP requirements pertaining to manufacturing, sanitation, and process controls. 

In short, the spring on-site inspection that your business has been expecting probably won’t happen.  Domestic and foreign manufacturers, nonetheless, should continue adhering to all cGMP and reporting requirements, as FDA indicated it may rely on such reports to determine manufacturer compliance.  In addition, we expect that the FDA will extend its suspension of non-critical foreign inspections beyond April.

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Client Alert | 4 min read | 08.07.25

File First, Facts Later? Eleventh Circuit Says That Discovery Can Inform False Claims Act Allegations in Amended Complaints

On July 25, 2025, the Eleventh Circuit Court of Appeals issued its decision in United States ex. rel. Sedona Partners LLC v. Able Moving & Storage Inc. et al., holding that a district court cannot ignore new factual allegations included in an amended complaint filed by a False Claims Act qui tam relator based on the fact that those additional facts were learned in discovery, even while a motion to dismiss for failure to comply with the heightened pleading standard under Federal Rule of Civil Procedure 9(b) is pending.  Under Rule 9(b), allegations of fraud typically must include factual support showing the who, what, where, why, and how of the fraud to survive a defendant’s motion to dismiss.  And while that standard has not changed, Sedona gives room for a relator to file first and seek out discovery in order to amend an otherwise deficient complaint and survive a motion to dismiss, at least in the Eleventh Circuit.  Importantly, however, the Eleventh Circuit clarified that a district court retains the discretion to dismiss a relator’s complaint before or after discovery has begun, meaning that district courts are not required to permit discovery at the pleading stage.  Nevertheless, the Sedona decision is an about-face from precedent in the Eleventh Circuit, and many other circuits, where, historically, facts learned during discovery could not be used to circumvent Rule 9(b) by bolstering a relator’s factual allegations while a motion to dismiss was pending.  While the long-term effects of the decision remain to be seen, in the short term the decision may encourage relators to engage in early discovery in hopes of learning facts that they can use to survive otherwise meritorious motions to dismiss....

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