FDA 483 - Abbott Medical - November 23, 2022

An FDA inspection of Abbott Medical in Arecibo, PR, revealed a significant deficiency in the documentation of corrective and preventive action (CAPA) activities. Specifically, a CAPA related to an adverse trend in pacemakers, which could lead to loss of pacing, lacked clear documentation for the rationale behind the scope of a field action. This resulted in an initial field action that did not include all potentially affected devices, necessitating a later expansion.