FDA warning letter issued

The Food and Drug Administration warned New Life Pharma after inspectors said the company blocked them from parts of a New Jersey plant making semaglutide and tirzepatide. (biospace.com) FDA inspectors visited the Northvale, New Jersey, facility from February 3 to February 13, 2026, and said New Life denied access to two production-suite areas marked “Area Not in Use.” The agency said the company told inspectors they lacked authority to enter those rooms. (biospace.com) The plant was making 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. FDA said refusing access violated rules against delaying, denying, limiting, or refusing an inspection. (biospace.com) Sterile drug manufacturing is the part of pharma where contamination controls are supposed to work like a sealed clean room around a surgical tool. FDA said New Life lacked procedures to prevent microbiological contamination in the areas inspectors could examine. (biospace.com) FDA also said New Life’s quality unit failed in its basic job of making sure the site followed current good manufacturing practice, the federal rules that govern how drugs are made and tested. Inspectors concluded the company lacked “the fundamental controls necessary to ensure the sterility” of its drug products. (biospace.com) The agency said the semaglutide and tirzepatide vials were also misbranded because the firm had not properly registered the facility or listed the drugs with FDA. New Life told FDA it stopped making drugs at the site a week after the inspection ended, then later said it had only paused production while it completed validation work. (biospace.com) FDA sent the warning letter on April 14, 2026, and gave the company 15 working days to respond in writing. The agency said New Life’s earlier response to the inspection report, known as a Form 483, was inadequate. (biospace.com) The case lands after FDA wound down its shortage-based enforcement discretion for compounded tirzepatide in March 2025 and for compounded semaglutide in spring 2025. On its shortage policy page, FDA said it could still act at any time on products that appeared substandard or unsafe. (fda.gov) Warning letters are FDA’s formal notice that it sees significant regulatory violations and expects corrections. FDA says the letters can be followed by later agency action and that the issues described may change only after further interaction with the company. (fda.gov) FDA’s drug center says warning letters are used to notify manufacturers of significant violations and to push them to fix them. In New Life’s case, the agency told the company it should not restart drug manufacturing at the facility and asked it to confirm that it will not make drugs there in the future. (fda.gov; biospace.com)