Heraeus Deutschland GmbH & Co. KG – FDA EIR, May 18, 2018

An FDA inspection of Heraeus Deutschland GmbH & Co. KG, located in Hanau, Germany, was conducted from May 14 to May 18, 2018. This cGMP inspection focused on the company's operations as a Human Drug Active Pharmaceutical Ingredient (API) manufacturer, guided by Compliance Program 7356.002F and ICH Q7 principles. The inspection encompassed all key systems, including Quality, Laboratory, Facilities and Equipment, Production, Materials, and Packaging and Labeling. The inspection resulted in a single written observation on an FDA Form 483, citing a deficiency in the company's written procedures for conducting effectiveness checks of Corrective and Preventive Actions (CAPA). Additionally, several verbal observations were communicated, highlighting further areas of concern. These included inadequate written sampling procedures, a noted lack of sufficient Quality Unit oversight, and inadequate validation of computer systems, impacting data integrity. Issues also arose regarding the verification of critical material remediation and the appropriate handling of non-critical material deviations through CAPA. The FDA classified this inspection as "Voluntary Action Indicated" (VAI). This classification requires Heraeus Deutschland GmbH & Co. KG to implement corrective measures to address the identified issues, particularly enhancing their CAPA processes, improving sampling procedures, strengthening Quality Unit oversight, and ensuring robust computer system validation and data integrity controls.