New Life Pharma LLC

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.

Taken together, these factors collectively demonstrate your objective intent for these products to be used as drugs. Thus, your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” are “drugs” as defined in section 201(g)(1) of the FD&C Act.

These products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for their labeled uses. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Based on a review of Agency records, no FDA-approved applications are in effect for your “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial.” Accordingly, these products are unapproved new drugs, and their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Failure to properly register and list

i. Misrepresentation of manufacturing operations in your FDA firm registration

Your firm failed to meet its registration and listing obligations under section 510 of the FD&C Act. Section 510 of the FD&C Act, 21 U.S.C. 360 requires, among other things, owners or operators of establishments engaged in the manufacture of drugs to register their establishments with FDA. Registrants must provide accurate information regarding the types of operations performed at each establishment (see 21 CFR 207.25(f)). A review of FDA’s drug registration database shows that New Life Pharma LLC registered as “Contract manufacturing for human over-the-counter drug products produced under a monograph.” However, our inspection revealed that your firm does not manufacture any OTC monograph drugs. Instead, your firm manufactures and distributes unapproved prescription drugs, including “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial.” Your firm's registration information misrepresents the type of drugs manufactured at your establishment and the nature of your manufacturing operations.

ii. Failure to obtain a labeler code to properly list your drugs with FDA

Your firm has also failed to fulfill its listing obligations under section 510(j) of the FD&C Act, 21 U.S.C. 360(j). New Life Pharma does not have any labeler codes assigned and has not listed any drugs with FDA, despite manufacturing drugs products for commercial distribution. Under 21 CFR 207.41, each registrant must list each drug that it manufactures for commercial distribution. Your firm manufactures various drugs, including finished drugs mentioned in this warning letter, but has not obtained a labeler code or listed any products under your labeler code.

The failure to register in accordance with section 510 of the FD&C Act, 21 U.S.C. 360, and the failure to list your drugs in accordance with section 510(j), 21 U.S.C. 360(j), is a prohibited act under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). In addition, your drugs are misbranded drugs under section 502(o) of the FD&C Act, 21 U.S.C. 352(o), because they were manufactured at an establishment not duly registered under section 510 and were not properly listed with FDA under section 510(j).

Accordingly, “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” products are misbranded drugs, and their distribution into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

During our inspection, our investigators observed specific violations including, but not limited to, the below. We reviewed your March 6, 2026, response to our Form FDA 483 in detail.

1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

Your firm manufactured multiple GLP-1 finished drug products such as sterile, multi-dose vials of semaglutide and tirzepatide, without appropriate procedures to prevent microbiological contamination of your drug products, purporting to be sterile.

Your firm did not adequately validate the conditions under which you manufactured drug products intended to be sterile. For example, you did not perform aseptic processing simulations (media fills), airflow visualization (smoke) studies, cleaning validation, or establish a routine environmental monitoring program. In addition, you manufactured these drug products under purported ISO 8 conditions without adequate supporting microbiological and particulate data. This did not meet critical area (ISO 5) standards for aseptic operations.

These deficiencies demonstrate that your firm lacked the fundamental controls necessary to ensure the sterility of your drug products. The requirements in 21 CFR 211.113(b) for sterile drugs are necessary to ensure sterility and safety of drugs administered to patients. Your failure to implement these requirements placed patients at serious risk of receiving non-sterile products, which could result in severe infections or other life-threatening complications.

2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your quality unit failed to ensure appropriate CGMP procedures and processes for the manufacturing of semaglutide and tirzepatide sterile multi-dose vials were established and followed. For example:

Failure to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Failure to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.167(a)).

Failure to establish and follow written procedures for cleaning and maintenance of equipment (211.67(b)).

Failure to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).

These failures demonstrate that your quality control unit did not fulfill its fundamental responsibility to ensure that your manufacturing operations comply with CGMP requirements and that your drug products meet appropriate quality standards. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations to ensure drug safety at https://www.fda.gov/media/71023/download.

During the inspection, your firm denied FDA investigators access to two areas within the manufacturing suite labeled “Area Not In Use” stating the investigators did not have authority to enter these areas. You confirmed to the investigators that you were refusing access.

This causes your drugs to be adulterated under section 501(j) of the FD&C Act, 21 U.S.C. 351(j). Under this provision, drugs are deemed adulterated if they have been manufactured, processed, packed, or held in an establishment where the owner, operator, or agent in charge has delayed, denied, limited, or refused an FDA inspection.

FDA’s inspection authority under section 704(a) of the FD&C Act, 21 U.S.C. 374(a), extends to all areas of drug manufacturing facilities, including areas designated as “not in use.” Your designation of certain areas does not limit FDA’s statutory inspection authority. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection at https://www.fda.gov/media/86328/download.

We reviewed your March 6, 2026, response to our Form FDA 483 in detail. Your response is inadequate because you fail to provide adequate evidence of corrective actions taken to bring your operations into compliance with CGMP or confidence that you can manufacture sterile drugs. Drug manufacturers labeling their product as sterile must recognize the serious public health implications of distributing a non-sterile product as it poses a significant health risk to patients.

On February 20, 2026, you committed to cease production of drug products at your facility. However, in later correspondence dated March 6, 2026, you indicated that production has been paused until appropriate media fill validation studies are completed, indicating that you intend to resume production after addressing the violations associated with sterile drug manufacturing.

Considering all the drugs you manufactured are not approved by the agency and your systems for manufacturing sterile drugs are wholly lacking, you should not restart drug manufacturing at this facility. In response to this letter confirm that you will not manufacture drugs in the future.

On February 19, 2026, FDA held a teleconference with you recommending you consider removing any batches of the GLP-1 drug products currently in distribution from the U.S. market.

On February 25, 2026, you issued a voluntary recall of semaglutide and tirzepatide sterile multi-dose vials due to lack of assurance of sterility. The recalls were posted to the FDA’s Enforcement Report website at:https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218926https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219020https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219021

The violations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

This letter notifies you of our findings and provides you an opportunity to address them. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012113519 and ATTN: Maria Pavco.