The Enterey Blog

Inspections by the FDA and foreign regulatory agencies have significantly increased since 2003 as manufacturing becomes more global and other countries regulate drug products. Between 2003 and 2005, the number of foreign inspections performed by the FDA ranged between 218 and 252. By 2007, that number had increased to over 450 per year and by 2009, it was up to nearly 550, dropping to 522 in 2010. In 2008, joint inspections began between regulatory agencies. That process continues today:

With the current leadership at the FDA stressing enforcement (as opposed to repeated warnings) for any violations or irregularities, 2010 saw the following actions:

• 10 seizures
  (5 CFSAN, 3 CDER and 2 CDRH)
   

• 17 injunctions
  (the highest rate since 2006)

   

• 673 warning letters
  (171 CDER, 204 CDRH, 15 CBER & 191 CFSAN ).  This was the highest rate in warning letters since 2004.

   

• 3,799 recall events
  (1,881 CBER, 258 CDER, 876 CDRH & 738 CFSAN) resulting in 868 different drug products being recalled from the market.

As demonstrated by the data collected by EFPIA, Agency inspections in Europe hit their high point in 2009, then began to level out somewhat. We believe this leveling is due to the major, worldwide regulatory agencies reaching their inspectional resources limits.  The FDA is still conducting the most inspections in Europe followed by the EU, then Brazil, South Korea, Japan and Mexico.  Of concern to us is the ever-growing number of inspectorates conducting “foreign” inspections.  And while China is not represented in the 2010 data, they are anticipated to become a major inspectorate in coming years.

As more and more countries begin implementing GMPs as a requirement for import, inspections of facilities in the US may continue to increase. However, Regulatory Agencies are also realizing that the number of manufacturing sites is growing faster, worldwide, than their resources available to perform inspections. We hope the number of inspections being performed will remain close to current levels.

Several factors make us think this will be true. For example, having the US FDA and other global inspectorates gain entrance to PIC/S will hopefully allow for better information-sharing between agencies, including inspection reports and resource sharing by inspectorates through joint inspections, one example being the recent EMA and FDA joint inspections which should reduce the number of on-site visits by Health Authorities.

At Enterey, in partnership with Mark Tucker, LLC, we can help you meet all your inspection management systems needs. This includes a system to help you self-identify and fully understand your compliance gaps; prioritize work and allocate resources to close those gaps; track gaps, actions taken and assess residual risk; fulfill the compliance requirements of ICH Q10; maintain an inspection-ready posture at all times; and respond to Agency findings systemically and quickly.

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Published by Mark Tucker | Partner of Enterey

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