Warning letter cites Semaglutide and Tirzepatide production without approved applications.
FDA issued Warning Letter 320-26-65 to New Life Pharma LLC at 265 Livingston Street, Northvale, NJ, on April 14, 2026, following an inspection from February 3-13, 2026. The firm was cited for manufacturing and distributing unapproved new drugs (Semaglutide Sterile Multi-Dose Vial and Tirzepatide Sterile Multi-Dose Vial) without FDA-approved applications, for misbranding due to improper firm registration and failure to list drugs with FDA, for CGMP violations including failure to maintain sterility controls for drug products purporting to be sterile, and for delaying, denying, limiting, or refusing to permit an FDA inspection. The products are also adulterated under sections 501(a)(2)(B) and 501(j) of the FD&C Act.
Sources
FDA Warns New Life Pharma for Unapproved GLP-1 Drugs
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