Saltigo GmbH has once again passed an inspection by the U.S. Food and Drug Administration (FDA) with a “No Findings” rating. This marks the third time in a row following previous inspections in 2003 and 2010. Saltigo Managing Director Wolfgang Schmitz emphasizes the importance of regulatory inspections. "The FDA inspection 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."
The inspection focused on general compliance to CGMP (Current Good Manufacturing Practice) rules including testing, production and quality assurance processes for active ingredients that Saltigo’s customers are looking to use in the United States. It also involved the inspection of the LANXESS subsidiary’s warehouses, laboratories and quality assurance systems over five days, the API production unit in Leverkusen and all associated facilities, from water treatment plants and cleanrooms to filling plants and process control technology. One significant component here was the assessment of whether a medical product can be manufactured at the company’s production facilities using technology that is recognized in the United States as state-of-the-art and in compliance with applicable CGMP rules.
Immediately afterwards, the FDA announced the results of its inspection, that can range from “No Findings” and “Form 483” (negative findings observed) to the “Warning Letter” (critical negative findings). “This excellent 'No Findings' result is a testament to our high standards, for an FDA inspection is a particularly tough test. But meeting CGMP requirements with ease and flexibility and doing so in all scales of synthesis is all in a day’s work for us,” says Dr. Carsten Hesse, who was responsible at Saltigo for the preparation and organization of the inspection. The Saltigo service portfolio addresses customer needs ranging from synthesis design and process development and optimization to support for registration and approval.
Saltigo GmbH is a leading supplier in the field of custom synthesis. The company of specialty chemicals group LANXESS (lanxess.com) belongs to the Advanced Intermediates segment, which achieved total sales in 2012 of EUR 1,674 million. Saltigo, headquartered in Langenfeld and with production facilities in Leverkusen and Dormagen, employs around 1,200 staff worldwide.