Category Archives: CGMP

Summer Enforcement Actions for Compounding Pharmacies and Outsourcing Facilities

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

July and early August 2017 saw another uptick in FDA actions associated with compounding pharmacies/outsourcing facilities.  In the past few years, the FDA has placed a disproportionate effort towards enforcement actions for these facilities.  We have addressed this focus and the history of these facilities in a previous blog.  The FDA published twenty-one (21) 483s and six (6) warning letters issued to these facilities in July 2017.  It’s clear that FDA’s extreme focus on these facilities continues and the compliance problems for these facilities have not been appropriately addressed. And, more problematic for me, is that firms do not appear to be learning from the enforcement actions taken against others in this area.   In addition, there have been several recalls of unexpired products and notices to healthcare professionals regarding adverse events apparently associated with these products and two consent decree agreements. Let’s look at these in turn:

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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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Our database now has 703,956 FDA inspections

Just a quick update – the FDAzilla Enforcement Analytics database was updated with data through April 25, 2017. We typically refresh the inspections data every 3 weeks or so, pair new warning letters with inspections every week, and add new 483s, EIRs, and 483 response letters every month.

As of now, our database has:

And the best part is that it’s all linked together.

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