New Life Pharma LLC — FDA Warning Letter (April 14, 2026)

Summary

Company

New Life Pharma LLC

Letter number

#725661

Issue date

April 14, 2026

Subject

CGMP/Adulterated and Unapproved New Drug/Misbranded

Word for word, from the letter of April 14, 2026

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, New Life Pharma LLC, 3012113519, at 265 Livingston Street, Northvale, from February 3 to February 13, 2026. Based on the inspection and a review of the evidence collected, we identified serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” 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 misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o) because you did not properly register you firm or list your drugs with FDA.

In addition, your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

Finally, during the inspection our FDA investigators documented that your firm delayed, denied, limited, and/or refused to permit an FDA inspection. Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 21 U.S.C. 351(j), your drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has delayed, denied, limited, and/or refused to permit inspection.

Introducing or delivering these drugs for introduction into interstate commerce violates sections 301(a), 301(d), 301(p), and 505(a) of the FD&C Act, 21 U.S.C. 331(a), 331(d), 331(p), and 355(a).

Your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” are “drugs” under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body. Multiple factors demonstrate that these products are intended for use as drugs.

For example, your registration as a drug manufacturer and listing of a semaglutide injectable drug in FDA’s drug registration and listing system provides evidence of your intent for these products to be used as drugs. (see 21 CFR 207.77(c)).

Additional evidence that your products are intended to be used as drugs (see 21 CFR 201.128) includes their composition, consisting of semaglutide or tirzepatide active pharmaceutical ingredients, which are well-known as the active ingredients in drugs approved for indications related to weight loss and management of type 2 diabetes; their design as lyophilized powder in sterile glass multi-dose vials with rubber stoppers requiring reconstitution and parenteral injection; and the circumstances of their distribution, including shipment to weight loss clinics (“med spas”) and cosmetic surgery medical practices. In at least some instances, you shipped the drug with bacteriostatic water purchased online, providing the means to prepare an injectable drug for human administration. In addition, your labels for your products include a National Drug Code (NDC), as well as the term “Rx-only,” and “Sterile Multi-Dose Vial; Refrigerate after reconstitution,” indicating use as a prescription drug.

Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-life-pharma-llc-725661-04142026

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