Baxter Healthcare Corporation received a Warning Letter from FDA dated May 31, 2013 regarding operations and processes at its Marion (North Cove), North Carolina and Jayuya, Puerto Rico facilities.
The Baxter facilities that received the FDA Warning Letter are not involved in the production of any treatments processed by Baxter’s BioScience Division including hemophilia clotting factors, albumin, immune globulin and alpha-1 augmentation treatments.
The facilities mentioned in this letter are both Medical Products facilities – the North Cove facility manufactures IV solutions and peritoneal dialysis solutions and the Jayuya facility manufactures large – and small-volume IV solutions, drug-reconstitution systems, parenteral nutrition products – and they do not manufacture BioScience products.
Baxter is committed to maintaining the highest standards of quality and safety for our patients, and we will continue our ongoing dialog with FDA to resolve any outstanding issues. Many corrective actions to issues raised in this letter have been implemented by Baxter as part of its continuous improvement efforts, including real-time environmental monitoring controls.
As part of its continuous improvement efforts, Baxter will continue to implement system and process enhancements to maintain the safety and efficacy of our life-saving and sustaining products globally.
Ronald K Lloyd
Baxter Healthcare Corporation