FDA 483 - Cambrex Charles City, Inc. - May 02, 2022

Cambrex Charles City, Inc. in Charles City, IA, an API manufacturer, was cited for significant deficiencies in laboratory controls and investigation procedures. The inspection revealed issues with scientifically unsound sampling and testing for microbiological contamination and diethylene glycol, as well as untimely and incomplete investigations into manufacturing deviations. These findings indicate a lack of robust quality control and investigation practices.