FDA 483 - Medtronic Neuromodulation - January 21, 2011

An FDA inspection conducted at Medtronic Neuromodulation, located in Minneapolis, MN, from November 17, 2010, to January 21, 2011, identified five significant observations documented in Form FDA-483. These observations highlight deficiencies in the company's quality system, particularly concerning the Synchromed II Drug Delivery System.The primary issues included inadequate process validation for the Synchromed II system, where various process changes and additions were implemented without proper qualification or re-qualification. Additionally, design validation for the Synchromed II was found insufficient, with discrepancies between units used for validation and those in production, and out-of-specification data in qualification records.Further observations noted deficiencies in complaint handling procedures. Returned products were not analyzed promptly, leading to inaccurate hazard coding and affecting product trending data. Numerous Product Comment Reports (PCRs) lacked accurate hazard codes or reference to corrective and preventive actions (CAPA), and some were not assigned for investigation. Finally, the documentation of CAPA activities and results was inadequate, specifically regarding motor stall issues in the Synchromed II and EL Pump, where identified mitigation actions were not implemented or justified. Design input requirements for Synchromed II were also not adequately documented, lacking verifiable details and showing discrepancies between specifications and testing.Medtronic Neuromodulation acknowledged these observations and "promised to correct" each identified deficiency, indicating a commitment to address the quality system shortcomings.