FDA 483 - Medtronic Puerto Rico Operations Co. - February 21, 2019

During an inspection conducted from February 5 to February 21, 2019, the Food and Drug Administration (FDA) issued a Form 483 to Medtronic Puerto Rico Operations Co., a medical device manufacturer. The inspection revealed two significant observations indicating non-compliance with regulatory requirements, specifically related to the Federal Food, Drug, and Cosmetic Act.

The first observation cited a lack of established or timely implementation of corrective and preventive action (CAPA) procedures. An example highlighted was a Design Development Plan (DDP 10025), initiated in February 2016 to resolve "Open Book" defects (linked to corrosion and moisture exposure in critical pump errors), which remained uncompleted at the time of inspection.

The second observation detailed insufficient investigation of device complaints. The FDA found that a complaint regarding a "Critical Pump Error" was confirmed as a "Force Sensor Flex Incomplete Plug In," yet no investigation was requested from the manufacturing site. Furthermore, out of approximately 102,000 complaints received over six months, only a minuscule fraction were sent for detailed review or manufacturing investigation.

Medtronic Puerto Rico Operations Co. is required to promptly address these observations by implementing robust corrective actions and establishing compliant quality system procedures to ensure product safety and effectiveness, in line with FDA regulations for medical device manufacturers.