FDA 483 - Abbott Medical - February 17, 2017

The FDA Form 483 details multiple violations at a medical device manufacturer. Procedures for corrective and preventive action (CAPA) were inadequate. Between 2011 and 2014, 42 Product Analysis Reports repeatedly failed to determine the cause of premature Greatbatch QHR2850 battery depletion, despite evidence of lithium cluster bridging. Failure investigations were not timely; a battery redesign project initiated in March 2013 did not lead to CAPA #13-017 until December 2013, with risk analysis completed in April 2014. The firm also failed to follow CAPA procedures in response to the August 2016 MedSec report, initiating a CAPA request in February 2017 after releasing updated risk assessments and new software versions.

Management review procedures were also inadequate, with incomplete information provided to management and medical advisory boards regarding premature battery depletion. A November 2014 presentation did not fully represent the occurrence rate of lithium cluster formation or note a death linked to this failure mode.

A correction or removal to reduce a health risk was not reported to the FDA. A design improvement to eliminate lithium cluster bridging in the 2850 battery header, implemented in 2014, was not reported to the FDA until August 2016.

Non-conforming products were not adequately controlled; ten recalled ICDs were shipped after the recall initiation