Regulatory Focus™ > News Articles > Medtronic Receives Warning Letter for Alleged CAPA Problems

Medtronic Receives Warning Letter for Alleged CAPA Problems

Posted 21 August 2012 | By Alexander Gaffney, RAC 

Medical device manufacturing giant Medtronic was hit with a warning letter from the US Food and Drug Administration (FDA) on 17 July regarding allegedly deficient operations at its Minneapolis-based Medtronic Neuromodulation manufacturing facility.

The letter, addressed to Chief Executive Officer Omar Ishrak, references a May 2012 inspection by FDA in which investigators found the facility's adherence to current good manufacturing practices (CGMPs) and Quality System Regulations (QSRs) to be lacking, rendering as adulterated some devices manufactured at the facility.

FDA said its inspection, like so many others this year, found deficiencies in the company's corrective and preventive action (CAPA) procedures, which, for at least one product, were purportedly non-existent. Gear motors for its SynchroMed II Pump were subject to hundreds of complaints regarding the device becoming corroded, seizing parts of the device and preventing it from delivering drug products to the patient. Medtronic said in its response that it is forming a Corrosion Task Force as part of its response to the CAPA problems, and FDA said it wished to schedule a meeting with the company regarding the initiative and other methods to mitigate risk of corrosion.

FDA officials also took note of inadequate review procedures for complaints and reports of specification failures received by the facility, highlighting dozens of complaints received by the company that were allegedly improperly categorized, incomplete, inadequately evaluated or uninvestigated.

Medtronic has since instituted changes that FDA said, "Appear to be appropriate," but will require follow-up inspection by the agency.

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