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

© Reuters. FILE PHOTO: Signage is seen exterior of the Meals and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Picture

By Patrick Wingrove

(Reuters) -U.S. drug regulators in November discovered high quality management lapses on the Bloomington, Indiana manufacturing unit of contract drug producer Catalent (NYSE:), together with discovery of a “pest” on the manufacturing line, in line with an inspection report.

Novo Holdings, the dad or mum firm of Novo Nordisk (NYSE:), on Monday introduced it was shopping for Catalent in a $16.5 billion deal that included its Bloomington plant, which it plans to promote to Novo Nordisk to assist it produce its well-liked weight-loss drug Wegovy.

Catalent is already the principle provider of fill-finish work, or filling and packaging syringes and injection pens in sterile situation for Wegovy. Novo’s predominant rival within the weight problems drug market, Eli Lilly (NYSE:), additionally reported on Tuesday that it makes use of Catalent to make a few of its medication.

Lilly, which is predicated in Indianapolis, declined to touch upon whether or not Catalent’s Bloomington plant helps manufacture its medication.

The inspection by the U.S. Meals and Drug Administration of the plant, performed from Oct. 31 to Nov. 15, famous 5 separate observations, together with that Catalent didn’t totally assessment unexplained discrepancies in sure batches of product.

The FDA’s report, obtained by Reuters through a Freedom of Data Act request, mentioned that the plant had recorded round 194 deviations between Oct. 31 2021 and Oct 31. 2023, that means some points of sure batches had failed to fulfill high quality management requirements. Catalent didn’t establish the foundation reason for 171 of these incidents, it mentioned.

The FDA mentioned the invention of a “pest” was outlined in certainly one of these data, however the company’s report was redacted to omit sure particulars and didn’t clarify what kind of creature was discovered nor exactly the place.

Some written procedures designed to forestall microbial contamination of sterile merchandise have been additionally insufficient, the FDA mentioned, noting one occasion the place investigators “noticed operators’ naked face/pores and skin and robes touching.”

In one other occasion, an “obvious brown residue” was discovered on the manufacturing line, whereas “ink” was found in one more.

Catalent mentioned it takes all regulatory inspections and any ensuing observations very significantly, and that it had despatched the FDA a plan for the best way to tackle the problems flagged in November.

Novo Nordisk didn’t instantly reply to a request for remark. In line with the FDA’s database of manufacturing unit inspections, Catalent is being given the prospect to voluntarily repair the problems recognized within the report.

The contract producer repeatedly breached U.S. sterile-safety guidelines in 2021 and 2022 and workers didn’t carry out required high quality checks, Reuters reported final yr, citing regulatory paperwork.