Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Fenwal, Inc. Lake Zurich, IL (10/14/2016): CBER’s Advertising and Promotional Labeling Branch has reviewed Presentation slides to introduce InterSol Solution to blood collection facility staff submitted by the firm and found them misleading because they present efficacy claims for Intersol, but omit all risk information. The agency said the firm was cited for similar violations in 2012 and it is concerned by its continued violative promotion.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm541775.htm

Humco Holding Group, Inc. Texarkana, TX (1/26): FDA inspected the firm 6/2015 and identified significant GMP violations for finished pharmaceuticals. The inspection also revealed that the firm manufactures and distributes unapproved new drugs.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm541308.htm