(Bloomberg) -- One of the Catalent Inc. factories Novo Nordisk A/S is buying to boost supply of its popular weight-loss injection Wegovy isn’t meeting safety and quality standards, according to an inspection document. 

Inspectors from the US Food and Drug Administration visited the Catalent plant in Bloomington, Indiana, in October and November and documented multiple instances of workers failing to ensure the quality and purity of drugs produced there, according to the 10-page document, obtained via a Freedom of Information request. It was also noted that a “pest” had been found somewhere on a manufacturing line handling syringes in June. The name of the product that had been produced on the line was redacted. Brown residue was also found in the area. 

“Catalent takes all regulatory inspections and any resulting observations very seriously,” Laura Hortas, a spokeswoman, said in response to an inquiry from Bloomberg News. Following the company’s “comprehensive response and action plans stemming from the November 2023 inspection,” Catalent is being given the chance to voluntarily fix the issues identified in the report.

Novo has agreed to pay $11 billion for the Bloomington facility and two others as part of an ambitious expansion plan to match supply of Wegovy with the seemingly insatiable demand for the obesity drug. Novo’s biggest rival, Eli Lilly & Co., also uses Catalent to make some of its drugs. 

“Catalent is an integral part, or manufacturer, of both commercial and pipeline products for the industry, especially in diabetes and obesity,” Lilly’s Chief Financial Officer Anat Ashkenazi said on an earnings call Tuesday. “And we have products with these sites as well.”

The Indiana facility was previously in the news when FDA inspectors found shortcomings there in 2022, leading to tight supply of Moderna Inc.’s Covid-19 vaccine. Then, in 2023, inspectors found more problems that led to the FDA rejecting Regeneron Pharmaceuticals Inc.’s application for a stronger formulation of its popular eye medicine, Eylea.

The most recent FDA report says procedures meant to prevent microbiological contamination at the plant weren’t adequate. 

The agency also found Catalent didn’t ensure qualified workers conducted visual inspections, which are often used to check vials for any particles. The factory also recorded 194 deviations in two years, meaning some aspect of a batch of product failed to meet standards. The company failed to identify a root cause for 171 of the incidents. Inspectors said no drugs or biological products had been rejected for related reasons. 

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