FDA EIR - Novo Nordisk Pharmaceuticals Co. Ltd - November 02, 2017

A routine FDA inspection of Novo Nordisk Pharmaceuticals Co. Ltd. in Tianjin, China, was conducted from October 30 to November 2, 2017. The inspection focused on the manufacturing and quality systems for their NovoPen Echo insulin delivery pens, a Class 2 medical device cleared through 510(k) processes. The scope included Management Controls, Corrective and Preventive Actions (CAPA), Production and Process Controls (P&PC), and Design Controls. Notably, the inspection concluded with no 483 Inspectional Observations or discussion items, indicating full compliance with regulatory standards at the time of the audit. This positive outcome followed a previous FDA inspection in 2009 that also yielded no observations. Despite the compliant inspection, the report referenced an earlier voluntary recall, initiated by the parent company Novo Nordisk A/S on July 5, 2017, concerning potential cracking of NovoPen Echo Cartridge Holders. This issue, related to contact with cleaning agents, posed a risk of reduced insulin dose delivery, with the cartridge holders manufactured at the Tianjin site. While this pre-existing recall was noted, it did not result in new violations during this specific inspection. The facility demonstrated adherence to various procedures, including Unique Device Identification (UDI) labeling requirements. Consequently, no new regulatory actions were required from this FDA inspection.