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As the exemptions of 2025 expired, the importance of inspection readiness moved to center stage as 2025 unfolded. Adding to the challenges was the confirmation from manufacturers that the FDA has started utilzing virtual inspections to check DSCSA readiness.

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FDA Begins Virtual Inspections, Highlights the Importance of Inspection Readiness

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As a product of innovation during the Covid travel restriction era, the FDA launched a Remote Regulatory Assessment program to allow agents to ensure continued safe operations of drug manufacturing and packaging. The FDA confirmed the approach remains in their toolkit through a publication in July of 2025 called "FDA's Remote Oversight Tools". It confirmed that the FDA utilizes a variety of tools to protect and promote public health. The FDA goes on to say "Remote regulatory assessments (RRAs) include voluntary interactive evaluations (such as remote livestreaming video of operations, teleconferences and screen sharing) in addition to requests to review records and other information under existing statutory or regulatory authority." The final note worth highlighting is the mention that these approaches are utilized both domestically and internationally. Through our collaborative work with the industry, we learned that this approach was utilized in 2025 to check DSCSA readiness including inspection of international locations. This should come as no surprise as international inspections have long been a challenge for the FDA where the important element of surprise can often be taken away through country custom requirements of confirmation of visits from host requirements. We applaud the FDA for taking innovative steps forward to address historic challenges in their mission to protect US patients.

We have published several articles over the past years to highlight the need to ensure that your organization takes DSCSA beyond system and process readiness by proactively establishing DSCSA effectiveness checks and mock inspections to help your team ensure they can properly communicate compliance and find any gaps that need to be addressed before inspections. These recent events reinforce the importance of having clear, documented, and actionable SOPs and processes for DSCSA compliance.  With enforcement ramping up, now is the time to ensure your company is audit-ready.

Ten Count continues to offer a free initial consultation to help trading partners of any size or sector understand their requirements and what is needed to comply, and have processes independently pressure tested.

Reach out to us through info@tencountconsulting.com

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