Registered products that are distributed to the US are under control of the US Food and Drug Administration (FDA). Part of the control by the FDA are inspections to determine if the specific products, services and implemented systems are in compliance with the current Good Manufacturing Practice (cGMP).

In 1983 the FDA requested the Swiss Authorities to carry out an inspection at DOTTIKON ES on behalf of the FDA in accordance with the terms of the agreement dated October 28, 1968, between the US and Switzerland regarding the inspection of bulk pharmaceuticals.

DOTTIKON ES' first FDA inspection took place in May 1996, followed by a second one in June 1999 and a third one in September 1999. The fourth and most current inspection was a four-day Pre Approval Inspection (PAI) for a new API that has been completed on October 25, 2007. The successful inspection confirmed that DOTTIKON ES is in compliance with the current GMP rules for the manufacture of intermediates and APIs for the US market.

DOTTIKON ES, of course, feels bound to maintain this high level of quality standards and shall do its utmost to make further improvements to keep up with any new requirements.