FDA issued a warning letter to New Life Pharma on April 14 after the company’s New Jersey facility blocked inspectors from two sections of its GLP-1 manufacturing suite.
The off-limits areas were labeled “Area Not in Use.” New Life told inspectors they didn’t have authority to enter, a stance that violates federal rules against delaying, denying, limiting, or refusing an FDA inspection. In the areas inspectors could access, they found CGMP failures: no adequate procedures to prevent microbiological contamination in sterile, multi-dose vials of semaglutide and tirzepatide. The quality control unit, per the FDA, failed its “fundamental responsibility” to ensure CGMP compliance. Products were also misbranded because New Life hadn’t properly registered the firm or listed the drugs with FDA.
The company agreed to stop manufacturing one week after the inspection closed, then walked it back. New Life told regulators production was only paused until it completed media-fill validation studies. FDA’s response: “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.”
Both products were recalled in February. The FDA found the company’s Form 483 response inadequate, citing a lack of corrective action evidence, which triggered the warning letter. New Life has 15 working days from April 14 to respond in writing.
— Sarah Chen