Christian Souza

Operations Manager
“I love all thinks track & trace.”

Christian Souza is one of the founders of TrackTraceRx. Christian Souza has been an entrepreneur for over 15 years starting many businesses. 10 years ago, he started ePedigree Solutions to tackle the Florida ePedigree compliance laws affecting every Wholesale Distributor in the state.


When he is not working he enjoys all things soccer, fishing, a good Cab and spending time with his family.

Blog Posts

How to Fill out your Wholesale Distributor/3PL Annual Report to the FDA

The purpose of the Drug Supply Chain Security Act (DSCSA) is to ensure the safety of drug products as they pass through the supply chain and end up in the hands of consumers. But there are so many provisions to the act that people in the pharmaceutical industry sometimes have a hard time figuring out how to handle certain situations.

Read Story

Will Negative Verifications Create Financial Strain for the Drug Supply Chain?

The purpose of the Drug Supply Chain Security Act (DSCSA) is to ensure the safety of drug products as they pass through the supply chain and end up in the hands of consumers. But there are so many provisions to the act that people in the pharmaceutical industry sometimes have a hard time figuring out how to handle certain situations.

Read Story

VRS - Verification Router Services Introduction: Complying With The DSCSA Saleable Returns Requirements

The purpose of the Drug Supply Chain Security Act (DSCSA) is to ensure the safety of drug products as they pass through the supply chain and end up in the hands of consumers. But there are so many provisions to the act that people in the pharmaceutical industry sometimes have a hard time figuring out how to handle certain situations.

Read Story

Time Is Running Out – Where Wholesalers Should Be In Regard to the Upcoming DSCSA Deadline

A look at the calendar tells us that summer is drawing to a close, and while that means trying to sneak in those last few bits of summer fun and recreation, wholesalers in the pharmaceutical industry are focused on something a bit more serious.

Read Story

Which Elements of the DSCSA Are Keeping Health Execs Up at Night?

At this point in 2019, we’ve long since passed the official midway point to complete DSCSA implementation and compliance in 2023. As each phase of the drug supply chain act has moved along, we’ve had a front row seat in witnessing the benefits of the process, along with a few growing pains along the way.

Read Story

FDA Violation issued! Form 483 Letter to one of Country's Largest Wholesale Distributor

2018 was a pretty significant year for the Drug Supply Chain Security Act (DSCSA) with a major deadline occurring last November. With this, there have been some rumblings in the industry as to when we were going to see the FDA issue its first sanction for a violation of the DSCSA.

Read Story

What’s Next for the DSCSA in 2019?

Members of the drug supply chain in the United States breathed a collective sigh of relief as the serialization deadline that had been extended to November 2018 finally passed. For many, the process took several years to fully implement with plenty of challenges along the way.

Read Story

7 Important Questions Answered About the DSCSA and Product Identifiers

Members of the drug supply chain, specifically wholesalers and manufacturers, have been working furiously towards meeting product identifier requirements for a fast approaching deadline. The deadline requires that pharmaceutical manufacturers adhere product identifiers to every package or homogenous case.

Read Story

FDA Issues Last Minute Draft Guidance to Address Human Readable Identifiers

As the November deadline for the DSCSA serialization quickly approaches, pharmaceutical manufacturers and other stakeholders within the drug supply chain have been working hard to ensure that they meet compliancy standards, especially considering that the approaching deadline is the cumulation of a year long extension granted by the FDA.

Read Story

What Happens to DSCSA Requirements in the Event of a Public Health Emergency?

The purpose of the DSCSA, more formally known as the Drug Supply Chain Security Act, is to create a system that makes it easier to track and trace prescription medications along the drug supply chain in the United States. Initiated in 2013, the DSCSA regulates transactions along the supply chain, including manufacturers, repackager, distributors, pharmacies and other dispensers.

Read Story

What DSCSA Means For Pharmacists

Since 1st November 2015, everyone dispensing prescription medicine in the US must comply with the Drug Supply Chain Security Act (DSCSA). That means every pharmacy, and every clinic, hospital, care facility and physician involved in the dispensing of any prescription medicine. DSCSA casts its net wide.

Read Story

The Importance of Lot Numbers to Dispensers Under DSCSA

It seems a common question that has arisen since the implementation of DSCSA is whether or not to enter a lot number when drug product changes hands, especially if the lot number isn’t received with a shipment from a wholesale distributor.

Read Story

A DSCSA Random Study Request

Today we received a request from one of our customers for assistance in responding to a particular letter they received from the U.S. Department of Health and Human Services, Office of Inspector General. We have assisted customers during audits in the past, but never seen a letter request like this one. Our customer was nice enough to allow us to share the contents of the letter for educational purposes.

Read Story

The Penalties Under DSCSA

The DSCSA regulation roll-out not only comes with complex compliance requirements, but also features some harsh penalties for those who fail to follow them. The FDA has already given extensions on some deadlines that recently passed,

Read Story

Preparation and Implementation of DSCSA Serialization and Traceability

Drug product down to the individual dose will now be traced by the FDA, made possible by a serial number printed on every label which will then be stored in the FDA’s database. The idea is to be able to trace any bottle of drugs anywhere in the supply chain back to its source, no matter whether it’s at a manufacturer, wholesaler, or dispenser (pharmacy) level.

Read Story

The DSCSA Deadline is Fast Approaching! Will You be Ready Come November 1st?

In preparation for deadlines fast approaching under DQSA and its Title II counterpart DSCSA, companies should be assessing how they can meet their compliance requirements with enough time to spare for successful implementation.

Read Story

A Comprehensive Checklist for DSCSA Compliance

With some DSCSA regulations already in effect, and the FDA enforcing the law since May 1, it’s very important to make sure you’re compliant. If you’re unsure about what’s required of you, take a look at our checklist and see if you’re missing anything.

Read Story

7 Things Dispensers Need to Know About the DSCSA

dispensers that are involved in a suspect product inquiry or recall, and cannot produce the required compliance documentation, will face penalties and fines.

Read Story

How EDI Can Help Automate your DSCSA Communication

One thing to remember is that EDI is not dependent on technology. There are ways to implement EDI, but there are different approaches to choose from. These approaches needs to be driven by your business needs, and not by a particular technology.

Read Story

DSCSA Template to send to your Trading Partners

We created a Word template that you can download and modify to fit your company message to your trading partners. Even if you are not a customer of ours, feel free to use this template.

Read Story

Results of a DSCSA US Pharma Traceability Survey

Also, only a small percentage of the respondents felt that only a small percentage of those calling the shots in their respective companies clearly understood the DSCSA and the relevant FDA guidelines.

Read Story

The Significance of Local Master Data as a Supply Chain Resource

For several years, majority of companies constituting the US drug supply chain have been facing a serious problem. The problem has had a drastic effect on the way internal IT systems work.

Read Story

HDA Updates their Q/A for the DSCSA

What requirements apply to nonsaleable returns to or from a wholesale distributor?

Read Story

Understanding Interoperability in the Context of the DSCSA

Organizations that make up the US drug supply chain are left with just two more weeks to meet the FDA’s extended deadline of 1stMay, 2015 for securing compliance with the transaction data exchange guidelines mentioned in the DSCSA.

Read Story

Understanding the Drug Supply Chain Security Act (DSCSA)

On November 27, 2013, President Obama signed into law The Drug Quality and Security Act (DQSA). Specifically in that bill, Title II of the DQSA, is the Drug Supply Chain Security Act (DSCSA).

Read Story

How to Notify the FDA of a Illegitimate Product

One of the questions we get at TrackTraceRx is, “how do I notify the FDA if i discover a counterfeit product within my supply chain?”

Read Story

How to Use the Extension in Deadline for DSCSA Data Exchange Enforcement to Your Advantage

the FDA, earlier this month, announced its intent not to take action against manufacturers, wholesale distributors and re-packagers who are still struggling to implement a robust transaction data exchange system within their respective portion of the medical supply chain.

Read Story

Choose the Right ERP System to Meet DSCSA Compliance

In this article we will discuss how to choose the right ERP system that can work with an external DSCSA solution provider. This integrated solution in passing transactional data (T3s) per the DSCSA requirement is really important in order to be fully automated with your supply chain to save on a lot of manual work.

Read Story

How to Handle DSCSA Exceptions: Your Next Nuisance

So, what exactly is an exception, anyway and why should companies care? It turns out that an exception refers to an honest mistake (rather than an intentional malice) during a shipment.

Read Story

There’s No Escaping the Serialization of the Pharmaceutical Industry

Regarding serialization, there exist a number of questions that need to be answered directly by the FDA. The first question is around the continuation of the usage of existing linear barcodes for serialization.

Read Story

Are Web Portals The Solution For DSCSA Transaction Data Exchange

The FDA has suggested that companies make use of secure web portals for achieving data exchange compliance. A number of companies are now considering web portals as a viable option for implementing data exchange requirements.

Read Story

Wholesale Distributor Annual Reporting Deadline

The DSCSA requires contact information to be submitted by wholesale distributors. FDA considers contact information to include the email address and telephone number of the person who will interact with the FDA

Read Story

Challenges with Using ASN/EDI for Passing Lot-Based DSCSA Transaction Data

Turbulent experience with ASNs should serve as an eye-opener for others. Whole sale distributors and pharmaceutical manufacturers who previously relied on ASN for conventional financial purposes cannot simply extend the same for transaction data exchange. With additional requirements such as saving pertinent data for six years, securing the relevant information, printing the documentation, and integration with ERP software, ASN clearly doesn’t cut it anymore.

Read Story