Warning letterFDA · Mar 31, 2026
Prime Sciences MARCS-CMS 721805, March 31, 2026
Named company: Prime Sciences
Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). These products are especially concerning from a…
Lot information: not specified in this record.