FDA Warning Letter: GLP‑1 Plant

The Food and Drug Administration told New Life Pharma not to restart drug manufacturing after the company blocked inspectors from parts of a New Jersey plant making semaglutide and tirzepatide. (biospace.com) Inspectors visited the Northvale, New Jersey, facility from February 3 to February 13, 2026, and the agency sent Warning Letter 320-26-65 on April 14. FDA said New Life denied access to two production-suite areas marked “Area Not in Use.” (changeflow.com) FDA said the plant made sterile multi-dose vials of semaglutide and tirzepatide, the active ingredients used in Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound. The agency said New Life told investigators they did not have authority to enter the blocked-off rooms. (biospace.com) Semaglutide and tirzepatide are glucagon-like peptide-1, or GLP-1, drugs, a class used for diabetes and weight loss. FDA says unapproved versions, including compounded versions, do not go through the agency’s premarket review for safety, effectiveness, and quality. (fda.gov) FDA said compounded drugs can be appropriate when a patient’s medical need cannot be met by an approved drug or when the approved product is not commercially available. But the agency also says compounded GLP-1 injections have raised concerns about product quality, including shipping and storage problems. (fda.gov) In the areas investigators could inspect, FDA said New Life lacked procedures to prevent microbiological contamination in sterile vials. The agency said the company’s quality unit failed in its basic job of making sure drugs met manufacturing standards. (biospace.com) FDA also said the semaglutide and tirzepatide vials were unapproved new drugs and were misbranded because the company did not properly register the firm or list the drugs with the agency. The letter says the products were adulterated under federal law because of the manufacturing failures and the refusal to permit a full inspection. (changeflow.com) New Life told FDA one week after the inspection that it would stop manufacturing at the facility, according to the letter. FDA said the company later indicated it had only paused production until it completed media-fill validation studies, which the agency read as a plan to resume operations. (biospace.com) The warning letter gave New Life 15 working days to respond in writing, and FDA said the company’s earlier response to a Form 483 inspection report was inadequate. FDA’s warning-letter database notes that issues in posted letters can later change after further contact between the agency and the company. (biospace.com)