Farmington Hills, Michigan, April 30, 2019 – LSPediA Inc., a leading software and service provider for the pharmaceutical industry, today announced the addition of notification for recalled and suspect product investigation to its Verifier® Verification Router Service.
“While suspect and recalled drugs are just a small portion of returned products, failing to identify those drugs and document their handling can be a serious liability for a distributor and a danger to the general public,” said LSPediA CEO Riya Cao. “The FDA is taking that part of the DSCSA rules very seriously.”
The added functionality of LSPediA’s Notifier® element manages inbound and outbound notifications for recalled products, suspect products, and investigations. Notifier® also provides automated workflow to initiate quarantines, conduct verification, file FDA 3911 reports, and notify trading partners, as required under the Drug Supply Chain Security Act. All events are captured with a complete history for six years and are easily accessible for audits.
FDA handing out fines amid suspect product investigations
The notification requirements of the DSCSA took on added importance earlier this year when it was revealed that the FDA issued a Form 483 Warning Letter in July to one of the country’s largest wholesale distributors. One year earlier, the same distributor was hit with a $150 million fine for mishandling suspicious products. This was the first enforcement action to directly cite DSCSA requirements and has put the pharma industry on alert to fully document and alert the agency and trading partners about suspect product investigation.
LSPediA’s Verifier® is already up and running, a stand-alone, turnkey VRS solution that has conducted nearly 50,000 successful scans in the three short months since its release. VRS already has emerged as the preferred platform for verifying returns among trading partner globally and in the U.S., with an eye toward maximizing revenue in the $11 billion market for saleable returns.
For more information or a demonstration of LSPediA’s Verifier® Verification Router Service with Notifier®, sign up for our weekly newsletter or email firstname.lastname@example.org.
About LSPediA – Life Sciences Solutions
LSPediA is a leading supply chain software provider for the pharmaceutical industry. LSPediA’s serialization solution RxChain enables pharmaceutical manufacturers, wholesale distributors, dispensers to manage data, distribute products, and track inventory at the serialized level. LSPediA’s Verification Router Service enables authorized trading partners to authenticate serialized products, verify returns, and deter counterfeiting.