FDA 483 - Nordmark Arzneimittel GMBH & Co. KG - February 13, 2017

Nordmark Arzneimittel GmbH & Co. KG in Utersen, Germany, received a Form 483 following a February 2017 inspection. Observations included failures in equipment maintenance plans, the use of un-validated electronic records for critical manufacturing calculations, and inadequate routine monitoring for cleaning validation of non-dedicated equipment. These issues indicate significant concerns regarding quality control and data integrity in drug substance and product manufacturing.