Merz Pharma Gmbh & Co. KGaAJune 10, 2022

FDA 483 - Merz Pharma Gmbh & Co. KGaA - June 10, 2022

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Merz Pharma GmbH & Co. KGaA in Reinheim, Germany, was inspected by the FDA from June 7-10, 2022. The inspection resulted in one observation regarding inadequate procedures for controlling non-conforming products. Specifically, the firm's procedures for processing time requirements were not adequately established.

Company: Merz Pharma Gmbh & Co. KGaA
Inspection Date: June 10, 2022
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Dedicated Device Cadre
John A. Sciacchitano (investigator)

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