PRESS RELEASE: New Data Provides FDA-Regulated Industries Unprecedented Insights Into FDA Inspection Trends and Enforcement Actions

CHICAGO, IL – May 14, 2015

Today, FDAzilla unveiled Enforcement Analytics, a ground-breaking data analytics tool that gives industry greater insights into FDA enforcement actions and inspection activity.  For the first time in the industry, data on FDA inspections, FDA inspectors, Form 483s, manufacturing sites regulated by the FDA, and FDA warning letters are all linked together, creating huge potential for industry insight.

“Smart data has arrived onto FDA inspections. We are proud to unveil Enforcement Analytics today, a much-needed innovation in the regulatory space for the thousands of professionals who work on keeping their manufacturing processes up to snuff for the FDA,” said Tony Chen, co-founder and CEO of FDAzilla.

Industry insiders also responded to the news today:

“FDAzilla is providing the only turn-key regulatory intelligence solution that directly links FDA inspections with Warning Letters. The power of the investigator profiles has given our organization the best insights for not just preparing for an inspection, but developing an effective quality system.” – US Head, Regulatory QA/QC, Medical Device Company based in Illinois

Particularly as many of the FDA-regulated industries continue to consolidate, the manufacturing of a company’s portfolio of products is often spread across internal and external sites. Utilizing the data within Enforcement Analytics enables users to quickly assess the inspection performance history of any potential partner, vendor, or competitor, quickly identifying red flags with the presence of warning letters and/or FDA 483s.

“All you have to do to type in a site’s address, and you can get the site’s entire history of FDA inspections, 483s, and warning letters,” said Chen.

In addition, companies can now perform “inspector due diligence” before their inspections, studying the inspector’s history, 483 issuance rate, and whether any of their inspections have led to a warning letter. This objective data rounds out this inspector due diligence process that has commonly occurred through informal networks and off-the-record phone calls. Through FDAzilla’s library of 483s, companies can also quickly identify key areas of focus of a particular inspector. Sometimes, trends can emerge, revealing a larger FDA movement towards or away certain issues.

A President of Regulatory intelligence consulting firm based in California noted today, “A component of inspection preparation includes gathering info on the inspectors who will conduct the inspection or have already shown up at your front door. The inspection analytics gathered by FDAzilla allows me to do this quickly and accurately… It’s all here in ONE place.”

As FDA priorities evolve, industry can stay ahead of the curve by analyzing the most comprehensive and updated FDA inspection and enforcement data through Enforcement Analytics.

Morris Sherwood, Director of Regulatory Affairs and Quality Assurance based in California noted, “In my decades of experience in the industry, I’ve never seen anything like this – having a centralized source for inspector and inspection data is extremely valuable.”