Medical device maker St. Jude Medical said Monday it received a warning letter from the Food and Drug Administration about manufacturing and quality-control problems at a California plant where it makes implantable heart defibrillators.
The company said in a regulatory filing that it is working to correct the problems at its Sylmar, Calif., plant and does not expect the citation to impact its financial results.
The warning was expected after St. Jude announced in October that the plant had been visited by FDA inspectors. The staffers found inconsistencies in how the company manufactured and documented defibrillators, which are devices implanted in the chest to correct dangerous heart rhythms.