- St. Jude Medical (STJ +1.7%) says in an SEC filing that it received a warning letter from the FDA regarding non-conformities at the Atlanta facility where it makes the CardioMEMS HF system, an implant to measure pulmonary artery pressure.
- The FDA has issued an early regulatory action based on inspections throughout June, and St. Jude responded regarding corrective actions.
- St. Jude says it continues to provide the FDA with monthly updates on remediating its concerns, and that it will keep manufacturing and shipping product from the Atlanta facility. It believes the FDA's concerns will be addressed without material impact.
- Shares were down 0.6% after hours prior to the filing.