DSCSA Enforcement Is Here and Some Distributors Are Not Ready

‍LSPedia is here to help.

In June 2025, the FDA issued a warning letter to a U.S.-based wholesale distributor that failed at nearly every level of DSCSA compliance. We're not naming names, but the violations speak volumes.

This wasn’t about confusing rules or a gray area. This was about a distributor ignoring the basics — and now facing the consequences.  15 days to reply to the notification with a comprehensive plan of action that satisfies the FDAs concerns, or face the consequences.

What Went Wrong

• Unlicensed Distribution
  Prescription drugs were shipped into multiple states without proper licensing — a clear violation of the law.

• Unauthorized Trading Partners
  The distributor bought product from a wholesaler that wasn’t even authorized. No vetting. No verification.

• Ignored Regulators
  Subpoenas and state board requests were left unanswered. When the FDA asked for records, the company replied that it didn’t keep them.

• Counterfeit Product? No Problem
  When notified of fake meds, they didn’t investigate, didn’t notify FDA, and didn’t warn trading partners. They just kept shipping.

• No Systems. No SOPs. No Records.
  Investigators found zero infrastructure to meet even the most basic DSCSA requirements.

Want to know more? The full 483 warning letter is posted on the FDA’s website here.

The Message Is Clear

The FDA isn’t warning anymore. It’s enforcing.

If your systems can’t validate licenses, verify product, respond to suspect events, and produce transaction data on demand, you are not ready. And waiting any longer is a risk you can’t afford.

Where LSPedia Comes In

We help trading partners pharmaceutical manufacturers, distributors and dispensers get ahead of enforcement, not scramble after it.

Our OneScan platform gives youprovides:

• Automated license and trading partner validation

• Real-time TI/TS capture and retention

• Built-in suspect product workflows and notifications

• System-wide visibility across your supply chain

No gaps. No guesswork. Full DSCSA readiness.

Don’t let your name be the next one in an FDA warning letter.
Talk to our team today and see how LSPedia keeps you compliant, protected, and prepared.