Posted 13 April 2017
By Zachary Brennan
The warning letter sent Wednesday from the US Food and Drug Administration (FDA) details four observations on failures related to corrective and preventive actions (CAPAs), controls, design verification and design validation.
The warning letter for the Sylmar, CA-based site, which manufactures implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, followed a 10-day FDA inspection in February. FDA previously issued a Form 483 for the site in February.
Abbott told Focus in a statement: "At Abbott, patient safety comes first. We have a
strong history and commitment to product safety and quality, as demonstrated by
our operations across the company. Abbott acquired St. Jude Medical in January
2017; the FDA inspection of the Sylmar facility, formerly run by St. Jude
Medical, began on February 7; and we responded to the 483 observations on March
13, describing the corrective actions we are implementing. We take these
matters seriously, continue to make progress on our corrective actions, will
closely review FDA's warning letter, and are committed to fully addressing
In one instance, FDA found that Abbott “underestimated the occurrence” of a possibly hazardous situation involving premature battery drainage.
FDA also found the company did not “confirm that verification or validation activities for the corrective actions had been completed, to ensure the corrective actions were effective and did not adversely affect the finished device.”
On 11 October 2016, Abbott initiated a recall for its Fortify, Unify and Assura Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) due to premature battery depletion.
But FDA found that subsequently, 10 ICDs subject to this recall were shipped from distribution centers to St. Jude US field representatives. And between 14 and 26 October, an additional seven ICDs, also subject to the same recall and in the control of St. Jude US field representatives, were implanted into patients.
Design Verification and Validation
In addition, FDA found Abbott failed to ensure that “design verification shall confirm that the design output meets the design input requirements,” and failed to accurately incorporate the findings of a third-party assessment into updated cybersecurity risk assessments for high voltage and peripheral devices.