FDA sends warning letter to Abbott regarding issues at California facility

The U.S. Food and Drug Administration (FDA) sent a warning letter to Abbott on April 12 alerting the company of violations at its manufacturing facility in Sylmar, California.

From Feb. 7 through Feb. 17, the agency visited the facility where Abbott manufactures its Fortify, Unify and Assura implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillator [CRT-Ds] and the Merlin@home monitor. 

The inspection revealed the devices were adulterated and did not conform with current good manufacturing practice requirements.

As of 3:50 p.m. Eastern Time on April 13, Abbott’s stock price decreased 1.61 percent since the beginning of the day to $42.78 per share.

The FDA said that Abbott failed to establish and maintain procedures for implementing corrective and preventive actions and said the company’s response was inadequate. The issues included lithium cluster bridging and premature depletion of Greatbatch QHR2850 batteries.

The letter also noted that St. Jude Medical recalled the Fortify, Unify and Assura ICDs and CRT-Ds on Oct. 11 due to premature battery depletion. However, the agency said that 10 ICDs that were subject to the recall were shipped to St. Jude Medical field representatives. In addition, seven ICDs that were subject to the recall were implanted in patients between Oct. 14 and Oct. 26.

Abbott completed its acquisition of St. Jude Medical on Jan. 4.

Further, the FDA said that Abbott did not verify that design output met the design input requirements for its Merlin@home monitor.

Abbott said in a statement to Reuters that the company responded to the FDA’s concerns on March 13 and took corrective actions.

“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 company said.