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# Fenwal InterSol Slides Mislead on Safety, Efficacy: FDA
- URL: https://www.fdaweb.com/fenwal-intersol-slides-mislead-on-safety-efficacy-fda/
- Published: 2017-02-16T12:00:00.000Z
- Updated: 2026-09-14T22:07:17.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137994

CBER’s Advertising and Promotional Labeling Branch says the presentation slides introducing Fenwal’s InterSol (platelet additive solution 3) Solution are misleading because they present efficacy claims but omit all risk information. A just-released 10/14/16 [Warning Letter](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm541775.htm?ref=fdaweb.com) says the violations are concerning from a public health perspective because they create a misleading impression about InterSol safety and effectiveness. The letter also expresses concern that Fenwal continues to use violative promotions for InterSol despite a 6/1/12 Warning Letter citing it for similar violations.

InterSol is described as an isotonic solution designed to replace a portion of the plasma used in the storage of Amicus-derived leukocytes apheresis platelets under standard blood banking conditions. The letter describes the Warnings and Precautions in InterSol labeling and says that the slide presentation “fails to provide facts material to the consequences that may result from the use of InterSol, including Warnings and Precautions, as well as the risk due to direct infusion.

The company was told to immediately stop disseminating violative promotional materials for InterSol and to respond with a list of all materials containing violations such as those in the letter and a plan for discontinuing their use. Fenwal also was told to indicate what policies and procedures it intends to adopt to ensure that its prescription drug promotional activities comply with the law and regulations, and an explanation of why and how it expects the policies and procedures to succeed.