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

During an inspection conducted from February 6-13, 2025, the U.S. Food and Drug Administration identified significant quality system deficiencies at Nordmark Arzneimittel GMBH & Co. KG, a drug substance manufacturer in Uetersen, Germany. The inspection, leading to an FDA Form 483, revealed several critical observations related to manufacturing and quality control, indicating non-compliance with Good Manufacturing Practice principles.Key issues included the Quality Unit's failure to evaluate and identify the root cause of metal particles found in in-process API materials, despite their rejection. The firm also neglected to initiate and approve process deviation reports for incidents such as a detected particle in an API reprocessing lot, directly violating their standard operating procedures. Furthermore, there was insufficient evidence to confirm the representativeness of in-process samples collected for API Process Performance Qualification lots, as required by their own validation plan. Lastly, the inspection noted a failure in contemporaneous documentation, with discrepancies in temperature recording for incoming samples.Nordmark Arzneimittel GMBH & Co. KG is expected to thoroughly address these findings by investigating the root causes, implementing robust corrective and preventive actions, and ensuring adherence to regulatory requirements to prevent recurrence and uphold product quality and safety.