Merz Pharma GmbH & Co., KGaA – FDA 483, Nov 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.
ID · f531c972-160a-4e9f-97ff-9b11868ea634
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