US FDA finds control lapses at Catalent plant being sold to Novo

FILE PHOTO: Signage is seen outside of FDA headquarters in White Oak, Maryland

By Patrick Wingrove

(Reuters) -U.S. drug regulators in November found quality control lapses at the Bloomington, Indiana factory of contract drug manufacturer Catalent, including discovery of a "pest" on the manufacturing line, according to an inspection report.

Novo Holdings, the parent company of Novo Nordisk, on Monday announced it was buying Catalent in a $16.5 billion deal that included its Bloomington plant, which it plans to sell to Novo Nordisk to help it produce its popular weight-loss drug Wegovy.

Catalent is already the main supplier of fill-finish work, or filling and packaging syringes and injection pens in sterile condition for Wegovy. Novo’s main rival in the obesity drug market, Eli Lilly, also reported on Tuesday that it uses Catalent to make some of its drugs.

Lilly, which is based in Indianapolis, declined to comment on whether Catalent's Bloomington plant helps manufacture its drugs.

The inspection by the U.S. Food and Drug Administration of the plant, conducted from Oct. 31 to Nov. 15, noted five separate observations, including that Catalent failed to thoroughly review unexplained discrepancies in certain batches of product.

The FDA's report, obtained by Reuters via a Freedom of Information Act request, said that the plant had recorded around 194 deviations between Oct. 31 2021 and Oct 31. 2023, meaning some aspects of certain batches had failed to meet quality control standards. Catalent failed to identify the root cause of 171 of those incidents, it said.

The FDA said the discovery of a "pest" was outlined in one of these records, but the agency's report was redacted to omit certain details and did not explain what sort of creature was found nor precisely where.

Some written procedures designed to prevent microbial contamination of sterile products were also inadequate, the FDA said, noting one instance where investigators "observed operators' bare face/skin and gowns touching."

In another instance, an "apparent brown residue" was found on the manufacturing line, while "ink" was discovered in yet another.

Catalent said it takes all regulatory inspections and any resulting observations very seriously, and that it had sent the FDA a plan for how to address the issues flagged in November.

Novo Nordisk did not immediately respond to a request for comment. According to the FDA's database of factory inspections, Catalent is being given the chance to voluntarily fix the issues identified in the report.

The contract manufacturer repeatedly breached U.S. sterile-safety rules in 2021 and 2022 and staff failed to perform required quality checks, Reuters reported last year, citing regulatory documents.

(Reporting by Patrick WingroveEditing by Bill Berkrot)