Once again, CU Chemie Uetikon was successfully inspected by the U.S. Food and Drug Administration (FDA) without any observation (no form 483 issued).
The on-site inspection took place in our Lahr manufacturing site from 06.June until 09.June 2006. The main subject of this pre-approval inspection was the manufacture of two APIs which were successfully transferred into the new P3 pharma production plant. The Lahr facilities have been successfully inspected by the FDA for many years and several active Drug Master Files are in place.
Website: www.fda.gov/cder
