The FDA has hit New Life Pharma with a warning letter after the company refused inspectors access to sections of a GLP-1 manufacturing facility.
FDA inspectors visited the company’s New Jersey facility in February. The inspection revealed New Life manufactured GLP-1 drug products including sterile, multi-dose vials of semaglutide and tirzepatide, the active ingredients in Novo Nordisk’s Ozempic and Wegovy and in Eli Lilly’s Mounjaro and Zepbound, respectively.
During the inspection, New Life denied the FDA access to two areas of the production suite, the agency said. The off-limits sections were labeled “Area Not in Use.” New Life told the inspectors they did not have authority to enter the areas, according to the FDA, and confirmed it was refusing access to those parts of the site. The actions broke the rules against delaying, denying, limiting or refusing an FDA inspection.
The inspectors found current good manufacturing practice (CGMP) compliance failings in the parts of the facility that they could access. For example, New Life manufactured semaglutide and tirzepatide vials without appropriate procedures to prevent microbiological contamination, the FDA said. Citing multiple failures, the agency said the quality control unit did not fulfill its fundamental responsibility to ensure the facility complied with CGMP requirements and that the drug products met appropriate quality standards. Inspectors concluded the company lacked “the fundamental controls necessary to ensure the sterility of your drug products.”
The agency also noted that the semaglutide and tirzepatide multi-dose vials were “misbranded . . . because you did not properly register you firm or list your drugs with FDA.”
The company agreed to stop manufacturing drug products at the facility one week after the inspection concluded, the FDA said. Yet New Life later told the regulator it had only paused production until it completed appropriate media-fill validation studies, according to the warning letter. The FDA interpreted the update as meaning New Life intends to resume production after addressing violations associated with sterility.
“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,” the FDA said. “In response to this letter confirm that you will not manufacture drugs in the future.”
The letter, which the FDA sent on April 14, gives New Life 15 working days to respond in writing. The FDA found the company’s response to its Form 483 inadequate, triggering the warning letter. Problems with the Form 483 response included a lack of adequate evidence of corrective actions to bring operations into compliance with CGMP. New Life voluntarily recalled semaglutide and tirzepatide vials in February.
https://www.biospace.com/fda/fda-issues-warning-letter-after-glp-1-manufacturer-refuses-inspectors-access
