FDA 483 - Nordmark Arzneimittel GMBH & Co. KG - August 12, 2019

Nordmark Arzneimittel GmbH & Co. KG, an API and finished drug manufacturer in Uetersen, Germany, was cited for two significant issues during an FDA inspection. The inspection revealed inadequate controls over computerized systems, specifically concerning data integrity and audit trail review, and failures in adequately investigating and documenting deviations and customer complaints. These observations highlight deficiencies in critical quality system elements.