FDA WARNING_LETTER - Medtronic, Inc. - May 09, 2012

The FDA issued a Warning Letter to Medtronic, Inc. following an inspection of their Neuromodulation facility in Minneapolis, Minnesota, from March 14 to May 9, 2012. The inspection revealed that Medtronic's implantable drug infusion systems, deep brain stimulation systems, spinal cord neurostimulation systems, nerve monitoring products, and other neurological medical/surgical products are adulterated. This is due to non-conformity with Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include:

1. **Failure to establish adequate procedures for corrective and preventive action (21 CFR 820.100(a))**: * Medtronic failed to identify actions to correct and prevent recurrence of non-conforming product, specifically regarding GCAPA 1485 related to motor corrosion in SynchroMed II Pumps, which has 567 complaints and remains open. An updated Health Hazard Analysis predicts additional patient injuries. * Data used for CAPA evaluation was incomplete, as noted in subsequent citations.

2. **Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints (21 CFR 820.198(a))**: * Patient and Technical Services (PATS) did not document complete complaint information for incoming calls, including details like withdrawal symptoms, specific