Preparing For A Successful FDA Inspection

By Peter Müller, Ph.D., CARBOGEN AMCIS AG

Routine inspections by the U.S. FDA are as important for non-U.S. pharmaceutical manufacturers as they are for U.S.- based companies. This is especially true for Swiss companies, which export a great share of their products to the United States. As a whole, Switzerland exports approximately 10 times more drugs and APIs than it consumes. For non-U.S. companies, which must undergo regular inspections by their native countries’ regulatory agencies, the FDA inspections provide extra validation that their products meet the highest effectiveness and safety standards and open the door to the U.S. market. An FDA inspection may seem intimidating, but it is a vital part of our business.