Category Archives: News

New FDA GMP Inspection Model

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

While the drug GMPs haven’t changed much, if at all, in recent years, FDA is planning for significant changes in how drug GMP inspections are scheduled and conducted.  The FDA recently made available a description of their new operating model that will ensure integration of review and inspection activities for human drugs.  This model continues FDA’s efforts to refine inspection operations as described in their recent reorganization of the Office of Regulatory Affairs (ORA).   It aligns and supports the New Inspection Protocol Program.  The MRA between the EMA and FDA adds flexibility for both health authorities maximizing their ability to focus inspection efforts on the highest risk sites, and rely on each other’s inspection outcomes.  Taken together, these changes will permit:

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US-EU Mutual Recognition Agreement of 2017

A Long Time in the Works

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

Implementation of the Mutual Recognition Agreement (MRA) for drug GMP inspections between the US FDA and the European Union (EU) inspectorates has been in the development since 1998 and was formalized this year. This agreement was driven by the reality of the changes in sites of drug manufacturing over the last decades. No longer is drug manufacturing primarily a ‘domestic’ function, either in the US or European countries.  The current supply chains are global with significant proportions of manufacturing performed across the globe, most significantly in India and China.  Both the FDA and EMA inspectorates have limited personnel and budgets and have been working to leverage their expertise and minimize where the two inspectorates visit facilities that their partner recently inspected, thus increasing their efficiency.  This allows each inspectorate to take a more risk-based approach to inspections and concentrate on those facilities that are in developing regions and provide a large percentage of either APIs or finished products that are prescribed and sold in the US and EU.

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

CHICAGO, IL – May 14, 2015

FDA Inspections at a glanceToday, 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. Continue reading

FDAzilla mentioned on front-page WSJ story


FDAzilla was mentioned in a front-page story today in the Wall Street Journal.  The article mirrors a key theme that we’ve talked about here – that the investment community is becoming more and more interested in FDA 483s, FDA inspections, and other government data.

Current and potential investors of your company may actually be reading your FDA 483.

Read the whole article here>> Continue reading

Funding Cutbacks at FDA: A Sequester Primer

At a time when FDA’s responsibilities continue to grow rapidly, the agency has been caught in an across-the-board reduction (sequester) in federal discretionary spending, effective March 2, 2013. Although Congress may yet reverse course and restore money to affected federal agencies, this is not considered a high probability. Continue reading