FDA 483 - Herbamed AG - September 11, 2023

An FDA inspection of Herbamed AG, a homeopathic API manufacturer in Bühler, Switzerland, identified three significant observations. The firm failed to perform annual Product Quality Reviews for multiple APIs shipped to the U.S., a repeat observation from previous inspections. Additionally, stability testing was not performed for a specific API lot, and numerous change controls initiated between 2015-2018 remained unclosed.