The Federal Food and Drug Administration has released the text of a warning letter sent to Little Canada-based St Jude Medical.
The letter concerns a plant in California that develops the wires connecting an implantable defibrillator to a patient's heart.
The watchdog agency had previously criticized testing and other procedures at the facility. Now, the FDA has categorized St. Jude's responses so far as either inadequate or their adequacy cannot be determined.
"The warning letter is just a distillation of the issues they felt were not adequately addressed in [St. Jude's] response," said David Furr, a medical device industry consultant.
Company spokeswoman Amy Jo Meyer said St. Jude will fully address the agency's concerns.
"St. Jude Medical is working closely with the FDA to further resolve the issues identified in the warning letter and all other observations from the FDA's inspection," Meyer said. "We take quality very seriously and remediating these issues is our highest priority."
As long as St. Jude does not satisfy the FDA, the agency can withhold regulatory approvals for new medical devices, as well as certificates needed to export devices to some countries.
Furr said the export certificates would not be a big deal since they'd pertain to limited products and the certificates are not required for devices shipped to most countries.