FDA 483 - Nordmark Arzneimittel GMBH & Co. KG - February 13, 2025

Nordmark Arzneimittel GMBH & Co. KG, a drug substance manufacturer in Uetersen, Germany, was inspected by the FDA and received four observations. The inspection revealed significant issues with quality unit procedures, including failure to investigate root causes for contamination and deviations, lack of evidence for representative sampling, and non-contemporaneous documentation practices. These findings indicate a need for improved quality control and data integrity.