FDA warns GLP‑1 maker

The Food and Drug Administration warned New Life Pharma after inspectors said the company blocked access to parts of a New Jersey plant making semaglutide and tirzepatide. (fda.gov)* FDA said it inspected New Life Pharma’s facility at 265 Livingston Street in Northvale, New Jersey, from February 3 to February 13, 2026, and issued Warning Letter 320-26-65 on April 14. The agency said the company’s “Semaglutide Sterile Multi-Dose Vial” and “Tirzepatide Sterile Multi-Dose Vial” were unapproved new drugs and misbranded. (ciopharma.com) The letter also said New Life’s manufacturing controls did not meet current good manufacturing practice rules, the basic standards FDA uses for how drugs are made and kept sterile. FDA said investigators documented that the firm “delayed, denied, limited, and/or refused” inspection, which makes drugs from that site adulterated under federal law. (ciopharma.com) Semaglutide and tirzepatide are the active ingredients in Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound. Those drugs became household names during the weight-loss boom, and FDA has spent the last two years warning patients and providers about unapproved or compounded copies sold outside the approved supply chain. (biospace.com, fda.gov) FDA says compounded GLP-1 drugs are not reviewed for safety, effectiveness, or quality before they are marketed, and that injectable versions can lose quality if they are shipped or stored improperly. The agency also says some GLP-1 bulk ingredients have been stopped at the border over manufacturing quality concerns. (fda.gov) The timing is tighter because FDA has already said the national shortages for tirzepatide and semaglutide injections are over. FDA declared tirzepatide resolved in a December 19, 2024 order and semaglutide resolved on February 21, 2025, ending the shortage-based rationale many compounders had used to keep making copies. (fda.gov, fda.gov) New Life had already recalled several semaglutide and tirzepatide vials in February 2026 for “lack of assurance of sterility,” according to recall listings that cite an FDA enforcement report dated March 11. One listing said 820 semaglutide vials and smaller lots of tirzepatide vials were part of the Class II recall. (ndclist.com) FDA’s warning-letter page says letters describe conditions the agency believes violate the law, but they can be followed by later exchanges that change a case’s status. For now, New Life is on the list of April 2026 drug manufacturing enforcement actions, and the next step is whether the company corrects the problems to FDA’s satisfaction. (fda.gov, raps.org) *The FDA warning letter page itself was not surfaced directly in search results I could open, but multiple secondary sources reproduced the letter number, date, company name, address, and findings from the posted letter.