FDA 483 - Merz Pharma GmbH & Co., KGaA - November 22, 2019

An FDA inspection of Merz Pharma GmbH & Co., KGaA, a drug substance and drug product manufacturer in Dessau-Rosslau, Germany, revealed significant deficiencies. Observations included failures to submit biological deviation reports for stopper particles, inadequate establishment of test method accuracy, and scientifically unsound laboratory controls for in-process materials. Additionally, the firm failed to follow written production and process control procedures for visual operator qualification.