US FDA Warning Letter Scrutinizes Abbott Over Cybersecurity, Battery Lapses

 
• By Ferdous Al-Faruque
  
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FDA investigators are concerned Abbott's St. Jude Medical subsidiary failed to adequately address concerns over cybersecurity vulnerabilities and premature battery drain on their cardiac devices manufactured at its Sylmar, Calif., facility.

In a US FDA warning letter dated April 12, the agency slammed St. Jude Medical Inc., a subsidiary of Abbott Laboratories Inc., for not following good manufacturing practices tied to cybersecurity vulnerabilities of its cardiac devices. According to FDA investigators, the company knew about the vulnerabilities back in 2014, yet did not act to address the risks contrary to its own remediation plan.

The warning letter posted also scrutinized the company's handling of a premature battery-drain risk that has been previously...

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