07/05/2010

www.rfp-international.com

Saltigo passes FDA audit

It involved the auditors inspecting Saltigo's production and quality assurance systems in Leverkusen over five days. As part of this pre-approval inspection, the FDA assesses whether a medical product can be manufactured at the company's production facilities using technology that is recognised in the USA as state-of-the-art and in compliance with applicable Current Good Manufacturing Practice (CGMP) rules.
The auditors also inspect quality assurance systems and all the facilities used, from water treatment plants and cleanrooms to filling plants and process control technology. Immediately afterwards, the FDA announces the results of its audit, ranging from "No Findings” and "Form 483” (negative findings observed) to the "Warning Letter” (critical negative findings).
The Saltigo GmbH service portfolio ranges from synthesis design and process development and optimisation to support for registration and approval. The company of speciality chemicals group Lanxess is headquartered in Langenfeld and with production facilities in Leverkusen and Dormagen, employs around 1,400 staff worldwide.

www.rfp-international.com