Saltigo GmbH has passed an FDA audit at its Leverkusen site. The audit focused on testing production and quality assurance processes for an active ingredient a client plans to supply in the U.S. As part of the pre-approval inspection, the FDA determines if a medical product can be manufactured at the company’s production facilities using technology recognized in the U.S. as state-of-the-art and in compliance with cGMP.

Saltigo’s managing director Wolfgang Schmitz commented, “The FDA audit is an internationally accredited seal of quality and recognizes all the work we have put in. This shows not just U.S. customers but also pharmaceutical companies throughout the world that with us the production of active ingredients is in safe and reliable hands.”