Bridge to Life Response to the Warning Letter from the FDA to Preservation Solutions
Bridge to Life Ltd. distributes Belzer UW® Cold Storage Solution and Belzer MPS® UW Machine Solution. Preservation Solutions, Inc. manufactures both products. You may have seen or been made aware of a warning letter from the US Food and Drug Administration to Preservation Solutions, Inc., dated August 21, 2017. It arose from a 9-day inspection of PSI, completed May 19. The inspection may have been triggered by earlier FDA concerns after a recall by another organ preservation solution company and FDA inspections of that company and its contract manufacturer.
The violations cited by the FDA are technical/procedural ones and do not directly affect product efficacy and safety. The FDA cited no instances of problems with the safety and efficacy of the products. There is nothing in the letter that refers to product contamination or lack of sterility. Preservation Solutions has been manufacturing UW Machine Perfusion Solution for 23 years and UW Cold Storage Solution for 8 years with no problems of product contamination.
PSI has worked with outside FDA consultants and its outside FDA counsel to respond to the FDA warning letter. The response was filed with the FDA on September 15.
We believe, and have been advised as such by our experienced FDA attorneys, that any action affecting our ability to supply Belzer UW® Cold Storage Solution or Belzer MPS® is highly unlikely. Bridge to Life continues to supply Belzer UW® Cold Storage Solution and Belzer MPS® UW Machine Perfusion Solution produced by Preservation Solutions, Inc.
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