FDA 483 - Croda Iberica SA - August 05, 2019

An FDA inspection of Croda Iberica SA, an API manufacturer in Fogars de la Selva, Barcelona, Spain, revealed significant deficiencies in their quality systems. Observations included improper storage of stability samples, multiple failures in quality unit responsibilities, and inadequate employee training practices. These issues collectively indicate a lack of adherence to current Good Manufacturing Practices.