Frequently Asked Questions About FDA Letter to Preservation Solutions
We have seen or heard about the FDA warning letter to Preservation Solutions, Inc., Bridge to Life’s contract manufacturer of Belzer UW® Cold Storage Solution and Belzer MPS® UW Machine Perfusion Solution. Is there a recall of these products?
No. There is no recall and there are no reported quality issues with the solutions produced by Preservation Solutions, Inc. and sold by Bridge to Life.
Should I continue utilizing Belzer UW® and Belzer MPS® solutions?
Yes. There is no need to change existing usage.
Is Bridge to Life able to continue to supply, given the FDA letter?
Yes. We have a strong level of stock and are maintaining production rates and delivery as normal.
Has Preservation Solutions, Inc. responded to the warning letter?
Yes. Preservation Solutions, Inc. promptly responded to FDA with additional information and corrective actions to address FDA’s concerns. They and Bridge to Life remain committed to patient safety and to adherence to FDA requirements.
How will we learn more?
As the communication continues with the FDA, we will post any relevant updates on our website. However, you can be sure that all action items will be handled in accordance with the FDA’s requirements.
What if I have other questions?