FDA WARNING_LETTER - Fenwal, a Fresenius-Kaby Company - May 07, 2013

On June 1, 2012, the FDA issued a Warning Letter to Fenwal, Inc. regarding promotional materials for InterSol® (Platelet Additive Solution), specifically the InterSol Solution Platelet Research Update Slides (2610), InterSol Bellyband (2619), and InterSol Brochure (2605). The FDA determined these materials were false and misleading, misbranding InterSol under Sections 502(a) and 201(n) of the Federal Food, Drug, and Cosmetic Act (the Act), and 21 CFR §202.1(e)(1) and (e)(6)(i).

The violations included unsubstantiated claims and broadening of indication, such as "InterSol Solution Reduces Transfusion Reactions…" and "Lower titers of anti-A and B were seen with InterSol Platelets…", suggesting benefits not supported by substantial evidence or clinical experience. These claims cited AABB 2011 abstracts, but the FDA was unaware of supporting data for InterSol. Additionally, the materials omitted crucial risk information, including warnings and precautions from the FDA-approved prescribing information, such as "InterSol solution is NOT FOR DIRECT INTRAVENOUS INFUSION." This omission also misbranded the product under Sections 502(a), 201(n), and 502(f)(2) of the Act, and 21 CFR