FDA EIR - Medtronic MiniMed, Inc. - March 10, 2023

An FDA inspection of Medtronic MiniMed, Inc. in Northridge, CA, was conducted from February 21 to March 10, 2023. This compliance follow-up aimed to assess the company's responses to issues identified in a June-July 2021 inspection and a December 2021 Warning Letter, specifically regarding compliance with medical device manufacturing regulations (Compliance Program 7382.845). The company is a registered manufacturer of blood glucose sensors and insulin delivery products. The inspection revealed three significant quality system deficiencies, documented on an FDA 483 form. These included inadequate procedures for: 1. Receiving, reviewing, and evaluating customer complaints. This issue was a recurring concern, not fully addressed from the previous inspection. 2. Establishing and implementing corrective and preventive actions (CAPA), also a persistent problem regarding action and effectiveness phases. 3. Controlling environmental conditions within the manufacturing facility. During the closeout meeting, Ms. Que T. Dallara, Executive Vice President, committed to correcting the first two observations and stated the third was "reported corrected, not verified." She pledged a formal response to the FDA 483 within fifteen business days. The FDA also reminded management of the potential for legal and advisory sanctions if comprehensive corrections are not implemented. Additionally, concerns were raised regarding unclassified complaints, insulin pump return data, and UDI labeling on sensor packages.