The FDA sent a warning letter to St. Jude Medical’s Implantable Electronic Systems Division as a follow-up to an inspection of the division’s Sylmar, Calif., facility in which the agency reported it observed nonconformities with Current Good Manufacturing Practice.
The FDA wrote that it will not grant requests for exportation certificates to foreign governments or approve premarket approval applications for Class III devices if quality system regulation deviations are reasonably related until the violations have been corrected, St. Jude reported in a regulatory filing. The warning letter, which was dated Jan. 10, does not identify specific concerns about the performance of the Riata ST Optim or Durata leads or any other St. Jude product, according to St. Jude.
St. Paul, Minn.-based St. Jude said that it will continue manufacturing and shipping product from the Sylmar facility. It said the warning letter is specific to the Sylmar facility and did not impact any other manufacturing facilities.
The FDA found what it described as several inadequacies during an inspection between Sept. 25 and Oct. 17, 2012. The list included findings concerning the facility’s process validation; design verification; design validation, including Durata risk analysis; internal auditor and design training; document control; and control of inspection, measuring and equipment.
St. Jude reported that it had provided written responses to the FDA detailing proposed corrective actions and initiated efforts to address the FDA’s observations of nonconformity. It said the warning letter was expected.