FDA Continues to Enforce DSCSA Across Sectors

Ten Count Consulting recently completed a study into the regulatory actions related to the enforcement of DSCSA.  Our findings confirmed that DSCSA-related compliance deficiencies remain a recurring observation in FDA 483 inspection observations.

These findings increased significantly upon the end of the connected trading partner exemptions for manufacturers in 2025 and have continued since .  While most manufacturers have systems in place to generate serialized labeling and exchange serialized data, many are still lacking in their ability to show compliance with the more nuanced requirements related to product verification and suspect/illegitimate event handling.

What Was Highlighted in FDA 483 Observations?

Since the end of the exemption, we found ten instances of manufacturers receiving 483 observations in DSCSA. The majority of these were related to not having clearly documented procedures or adequate evidence of training to handle requirements such as:

• Ability to identify and quarantine suspect product
• Notify the FDA and trading partners within 24 hours as applicable
• Ability to perform or respond to product verification or trace requests
• Receive notifications from trading partners, state, or federal authorities

It is worth noting that  findings were not exclusive to manufacturers and 483 observations were made to repackagers, distributors, and a dispenser.

For the dispenser, the observations were related to lacking systems related to checking authorization of suppliers under the ATP requirements of DSCSA as well as failure to ensure that only serialized (or exempt) products were received.

Trading partners across the supply chain should be considering the risk related to FDA 483 and/or state inspection observations and related warning letters.  In early 2025, we held a 483 webinar with Jonthan Keller from Faegre Drinker where we discussed that such events can have significant implications.

What Risks Are Some Key Risks to Consider?

1. Fines and related legal fees can run from $50k or more per incident and increase exponentially for larger trading partners.
2. Observations require significant resources at time to address and can hamper planned operations and fiscal forecasts.
3.  Brand and product reputation are often impacted, leading to greater scrutiny from trading partners, customers, and regulators who look to avoid cascading risk.

How Can You Ensure Your Organization is Avoiding These Risks?

• DSCSA Domain Knowledge.  Employees who do not fully understand or have a limited experience in DSCSA can easily overlook requirements or allow prior developed systems to fail.    We recommend independent training that focuses on the core requirements of DSCSA based on your organizations DSCSA roles and is not limited to understanding a single software solution or limited to standards.  Check out DSCSA.LearningCart.Com for proven training for a small group up to an entire organization.
• Proactive effectiveness Checks and Mock Inspections.  Don’t wait till an actual inspection knocks on your door  to realize your organization has gaps in its ability to demonstrate compliance.  We have completed over 50 assessments across all sectors of the supply chain from single to world wide site organizations and  scalable assessments that can enhance existing internal inspections or be run as stand-alone DSCSA checks.
• Documented Training.  Most organizations tend to focus on ensuring there is documented training of SOPs, which is foundational to compliance.  We recommend ensuring your training program goes wider by including developed e-learning in your LMS or compliance tracking systems.  We offer subscriptions to syndicated training that can be customized with your organization's logos and run inside your own systems. 

Let’s be clear! 

Preparing for inspections can sometimes be hard to justify with leadership and unplanned budgets.  With now very clear examples and costs of continuing state or federal enforcement, you have clear evidence to bring to leadership to help demonstrate this unaddressed risk.  Whether you leverage Ten Count Consulting or any other options, we urge you to highlight this trend with leadership before it is too late. An announce of prevention is far more efficient then pounds (or dollars) of cure.

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Please check out our training platform at dscsa.learningcart.com

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