ECA Activities - FDA Warning Letters Report

Handbook and CD-ROM Now Available

In a first step, the GMP-relevant warning letters are separated from those regarding other areas, e.g. wrong information on the package and on the leaflet. Other warning letters irrelevant to GMP are those concerning different industries, like the food industry.

The GMP-relevant warning letters deal with deviations from the CFR paragraphs of the cGMP Guide (21 CFR 210/211). All deviations are then compiled within the framework of a statistical analysis. The result is a top-10 list for finished medicinal products and a top-3 ranking for blood, blood products and biologics.

What is especially useful is the compilation of "original citations", i.e. the deviations from the CFR paragraphs are listed for each year. Since the deficiencies in API production are of particular importance to the respective manufacturers, original citations are also listed for this area. Here you can find an example of this list for finished pharmaceuticals from the latest Warning Letters Report.

For the period observed, the Warning Letters Report offers another source of information: The frequency of the individual deficiencies is indicated for each year. From these numbers one can conclude where the focus of inspections was placed and where this trend points. Here you can find an example from the 2005 Report (comparison with 2004).

For further information on the current Warning Letters Report, please consult the table of content. The Report can be ordered at EUR 399. Together with the Report, you will receive the FDA Navigator CD-ROM. This CD is an excerpt from the GMP Guideline Manager 9.0 CD. All GMP-relevant FDA documents are arranged in a clear tree structure (here you will see a screenshot). A full-text search enables you to search all guidelines, warning letters and the Warning Letters Report for a keyword. To order the Warning Letters Report and the FDA Navigator CD, please go to our GMP Publications page.