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FDA update May 1, 2012

Interactive Map of Fiscal Year 2011 FDA cGMP Warning Letters

When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. According to the evaluation done 2010 was the year in which the issuance of Warning Letters to different companies for cGMP/QSR/MDR issues was highest in US. Recently a research was made by a company named In Pharma Technologist which outlines an interactive map of cGMP Letters that were issued globally in Fiscal 2011.

The following are the highlights of an interactive map showing global distribution of US FDA cGMP warning letters in Fiscal 2011:

  • The US Food and Drug Administration( FDA) continued to crack down on overseas manufacturing plants with a 40 % increase in fiscal 2011
    • Sites in India and Mexico accounted for one third of production plants cited in FDA cGMP(Current Good Manufacturing Practices) warning letters last year.
  • North America and Western Europe account for many of the Warning Letters.
  • For the first time since 2009 FDA sent no Warning Letters to facilities in South America, leaving India and China as the emerging market hotbeds of regulatory enforcement actions.

Following is the link which will provide a thorough view map of the sites of production plants and every other facility named by FDA in fiscal year 2011 warning letters:

http://www.in-pharmatechnologist.com/Regulatory-Safety/Interactive-map-of-fiscal-2011-FDA-cGMP-warning-letters?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright

To summarize, the discussion provides an overview of the approach of FDA in issuing Warning Letters globally in fiscal year 2011 and throws light upon some of the prime regions which were target of the FDA enforcement actions.

If you want to get an overview about interactive map of FDA cGMP warning letters for Fiscal 2011 or procure in detail information about the same please contact mdi at info@mdiconsultants.com

If you would like to discuss the FDA regulatory strategy and what it can mean to you please contact us at info@mdiconsultants.com and ref: FDA “warning letter map”