Abbott Takes Action On FDA Warning Letter

In response to a Wednesday letter by the U.S. Food and Drug Administration, which highlighted numerous regulatory violations on the part of Abbott Laboratories ABT, Abbott told Benzinga that “patient safety comes first” and the firm prioritizes compliance with regulatory standards.

The FDA Letter

Additionally, the spokesperson noted that the FDA issues relate to a newly procured branch of business.

“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,” an Abbott representative said. “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 FDA's concerns.”

The FDA raised issue with “adulterated” devices manufactured by Abbott, including the Merlin home monitor and the Fortify, Unify and Assura implantable cardiac defibrillators. The process to develop, pack, store or install the devices were “not in conformity” with Quality System regulatory requirements.

The Administration also listed a number of standard violations among Abbott’s business practices, including failure to implement or report corrective and preventive strategies, inadequate responses to the discovery of insufficient battery life and cybersecurity risks, and failure to report the findings of third-party risk assessments.

According to a UBS report, Abbott executives do not expect the warning letter to affect presently marketed products, but it could delay future product approvals.

Abbott shares opened down 2.4 percent Thursday and were trading down 1.7 percent at the time of publication.

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