The FDA has issued a warning letter to Abbott citing serious CAPA and other violations at its St. Jude Medical defibrillator manufacturing facility in Sylmar, Calif.
During a Feb. 7-17 inspection, the agency found the firm underestimated the problem of premature battery drainage on some devices, and continued to ship the devices.
The agency says Abbott shipped 10 implantable cardiac defibrillators from one of its distribution centers despite a recall of its Fortify, Unify, and Assura products because of the battery drainage problem.
The company repeatedly concluded that the cause of the battery draining “could not be determined” although a supplier’s analysis indicated the problem was caused by shorting of the lithium clusters.
Abbott based its risk evaluation on “confirmed” cases and did not consider the potential for “unconfirmed” cases to have been shorts, so it underestimated the occurrence of the hazardous situation, the agency said.
The firm failed to follow it CAPA procedures and conducted a risk assessment and a corrective action outside the CAPA system, the agency said.
The FDA also cited Abbott for failure to ensure that the defibrillators only grant remote access to authorized users — placing the devices at risk of cyber hacking.
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