How to prepare for the U.S. FDA?

New technical article from gempex:

"FDA is coming" 
- Practical experiences, applicable strategies as well as tips, tools and checklists for a successful inspection.
- A guide to preparing for U.S. inspections.

The U.S. Food and Drug Administration (FDA) is an international highly respected health authority. Biotech, pharmaceutical, and other cGMP industries depend on the outcome of their foreign inspections. 

FDA inspections are means of strict enforcement of cGMP requirements. There are significant differences regarding the history, culture, and inspection behavior of FDA investigators and European inspection practices. 

Inadequately prepared operational sites will encounter different problems which can often be avoided. There are several items and “hot topics” to be considered in preparing for the FDA investigations. 

The pre- and post-inspection phase is important to assure a successful outcome as well as the intense conduction phase of FDA investigations on site.

The new technical article "FDA is coming" by Dr. Ralf Aubeck, gempex GmbH, published in pharmind 04-2022, presents experiences, applicable strategies and tools to facilitate success and mitigate the amount of potential inspection follow-up activities. 

By the way: Look forward to the inspection in a relaxed manner - here gempex offers extensive support with the goal of Inspection Readiness. Frank Studt, Managing Director, gempex GmbH, is available for a discussion. Interested please contact

The German language article can be made available free of charge via