FDA Warning Letter: New Procedure established

With the appointment of Dr Margaret Hamburg as Commissioner the US Food & Drug Administration (FDA) also introduced a number of reform provisions. One of the top issues is the supervision of medicinal products and API manufacturers. A lot of provisions have already been initiated. One of them is the accelerated administrative process for Warning Letters. The review will be managed short-term in the future. If the answer is not sufficient from the FDA's point of view, the company will receive a Warning Letter. This Warning Letter - and this is new - will be published together with the so-called "Response Letter", i.e. the response to the inspection findings from the audited company.

The impact of this new strategy is already visible: the number of Warning Letters almost skyrocketed, and this means that the companies affected are only one step away from an import alert. If the authority takes this measure, a company cannot import their products into the country any more - the "worst case scenario" for every pharmaceutical manufacturer.

Since 1 September 2009 the FDA also issues so-called "Close Out Letters". These letters are issued when a company eliminated all deficiencies the authority addressed in its Warning Letter.

In this regard the FDA also revised its website, which now provides new search functionalities. You can find the Warning Letter starting page here. However, in the quite large number of Warning Letters which are mostly related to the food area, it is still quite difficult to find the relevant Warning Letter with regard to medicinal products, APIs and Biologics. For that reason the ECA website allows a full-text search in the relevant GMP Warning Letters. This means that you will be able to find frequently listed deficiencies for your own compliance review. On top of the site just type in your keyword (e.g. validation) and choose "FDA Warning Letters" from the drop down menu in the field "Search in".

Oliver Schmidt
On behalf of the European Compliance Academy (ECA)

PS: You can also order the comprehensive and annually revised Warning Letters Report, including a thorough analysis - just see GMP Publications.

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