Ongoing inspections at the Sylmar pacemaker factory of St. Jude Medical Inc. will likely result in a warning letter from the Food and Drug Administration, company executives said.
The products made at the east San Fernando Valley facility have come under scrutiny by the FDA in the past year. In November 2011, the St. Paul, Minn.-based company recalled its Riata ICD implantable defibrillator made in Sylmar due to problems with the insulation on the leads that connect the device to the heart.
During a conference call Oct. 17 to discuss third quarter earnings, St. Jude Chairman and Chief Executive Dan Starks disclosed the FDA inspections to assure investors the company takes the matter seriously.
“We want people to understand that St. Jude Medical is realistic about the role warning letters play in today's regulatory environment and we want investors similarly to be realistic about it,” Starks said during the call.
FDA warning letters are a step below an enforcement action by the agency and offer companies the opportunity to fix any procedural or manufacturing flaws before more significant regulatory action is taken.
Starks would not disclose specifics of the FDA letter but said he does not expect it to slow sales of implantable defibrillators or pacemakers.
A corporate restructuring at St. Jude resulted in layoffs of 57employees at the Sylmar plant in August, with another 42 employees being let go this month.
The Sylmar location will maintain an employee base of more than 1,700 workers following full implementation of those cuts.
Mark R. Madler