FDA EIR - Merz Pharma GmbH & Co., KGaA - November 22, 2019

An FDA follow-up inspection of Merz Pharma GmbH & Co., KGaA, located in Dessau-Rosslau, Germany, was conducted from November 14 to November 22, 2019. This inspection served as a follow-up to a pre-license inspection for drug substance and drug product manufacturing, and a for-cause inspection under the Compliance Program for Licensed Biological Therapeutic Drug Products. The company is registered with the U.S. FDA. The inspection identified four main deficiencies. These included the failure to submit Biologic Product Deviation Reports (BPDRs) to the FDA for stopper particle issues in a specific product between 2016 and 2019. Additionally, the bioburden method for in-process control testing was found to be incomplete, lacking specific component testing. Deficiencies were also noted in the acceptance criteria for endotoxin testing and in the test kit used to qualify visual inspection operators, which contained an insufficient number of defect vials for stopper particles. This follow-up addressed previous findings from an inspection conducted in March 2019, which resulted in fourteen observations related to inadequate manufacturing controls, visual inspection, microbial control, validation practices, document completeness, deviation handling, and quality oversight. The overall inspection conclusion was "Voluntary Action Indicated" (VAI), meaning the FDA expects the company to voluntarily address the identified issues. Furthermore, an additional inspection was recommended for Merz Pharma's Frankfurt site to audit adverse event, field alert report, and complaint handling processes, as these functions are managed there.