Six Firms Land Untitled Letters Over Confusing Allergenic Extract Descriptors
CBER has issued nearly identical untitled letters to six manufacturers of allergenic extracts because multiple names were used to reference source materials, which could lead to treatment errors.
The six companies are: Allergy Laboratories, Antigen Laboratories, Jubilant HollisterStier, Greer Laboratories, ALK-Abello and Allermed Laboratories.
According to the letters, the companies identified some of the products simply as “mixed” and used names for source materials that differed from ones used by other manufacturers for the same material, CBER says.
CBER asked the firms to notify it regarding steps they’ll take to properly identify the extracts, timelines for submitting labeling supplements and plans to update establishment registration and product listing information.
View the untitled letters at www.fdanews.com/10-08-15-AllergyLabs.pdf, www.fdanews.com/10-08-15-AntigenLabs.pdf, www.fdanews.com/10-08-15-JubilantHollisterStier.pdf, www.fdanews.com/10-08-15-GreerLabs.pdf, www.fdanews.com/10-08-15-ALKAbello.pdf and www.fdanews.com/10-08-15-AllermedLabs.pdf. — Kellen Owings