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 ...