The FDA took St. Jude Medical to task in a warning letter that followed the agency’s inspection of a facility that manufactures the Durata and Riata ST Optim implantable cardiac leads. The agency gave St. Jude 15 business days to specify how it was taking corrective action.
The letter, which FDA made public on Jan. 15, reviewed violations identified during the inspection of St. Jude’s Sylmar, Calif., facility on Sept. 25 through Oct. 17, 2012, and responses that the agency determined were inadequate and lacking evidence. The FDA had determined that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements.”
The FDA wrote that St. Jude’s response failed to provide descriptions or evidence of corrective action or evidence of implementing corrective action. “Your firm should take prompt action to correct the violations addressed in this letter,” the FDA wrote. “Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.”
The letter continued to list potential FDA actions, including civil penalties and alerting other federal agencies that award contracts about the warning letter. In a regulatory filing, St. Jude previously had reported the FDA warned that it could choose to not approve premarket approval applications for some Class III devices and not grant Requests for Certificates to Foreign Governments if violations of quality system regulations had not been corrected.
The FDA requested that St. Paul, Minn.-based St. Jude notify it within 15 business days of the letter’s receipt “of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.”
It asked for a comprehensive response that included documentation of the corrections or corrective actions, planned corrections or corrective actions with a timetable for implementation or, if corrections and corrective actions could not be completed within the 15-day window, an explanation and completion date.
The FDA letter is available here.