FDA 483 - Merz Pharma GmbH & Co., KGaA - November 22, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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