Merck KGaA – FDA EIR, Sep 8, 2017

An FDA inspection of Merck KGaA, an active pharmaceutical ingredient (API) and excipient manufacturer located in Darmstadt, Germany, took place from September 4 to September 8, 2017. The inspection, conducted under cGMP regulations and guided by CPGMs for API processes and pre-approval inspections, assessed the company's Quality, Production, Facilities and Equipment, Laboratory, and Material systems. During the inspection, two verbal observations were made: the process for a specific API was not validated to current standards, and the cleaning validation for another manufacturing process was deemed inadequate. However, no formal FDA-483 Inspectional Observations form was issued to Merck KGaA. As a result, the inspection was classified as "No Action Indicated" (NAI) for Good Manufacturing Practices (GMP), with a recommendation for approval of a specified drug master file. Given the NAI classification and the absence of an FDA-483, no formal regulatory actions were explicitly required from the company following this inspection. The site's registration was current.