|
|
|
|
FDA |
 |
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 EXCLUSIVE SYNTHESIS 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 and was followed by
subsequent inspections in June 1999, September 2004, and October 2007. The fifth
and most recent inspection was a five-day FDA audit with focus on a new active
pharmaceutical ingredient (API) for the US market and has been completed with no
483 observation on September 28, 2012. 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.
|
|
|
|
|
|
© Copyright 2013, DOTTIKON ES HOLDING AG
|
|
