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

Catalent

07/02/2024 17:55

(Adds Catalent comment in paragraph 10)
    By Patrick  Wingrove
       Feb 6 (Reuters) - U.S. drug regulators in November found
quality control lapses at the Bloomington, Indiana factory of
contract drug manufacturer Catalent  CTLT.N , including
discovery of a "pest" on the manufacturing line, according to an
inspection report. 
    Novo Holdings, the parent company of Novo Nordisk
 NOVOb.CO , 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  LLY.N , 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 Wingrove
Editing by Bill Berkrot)
 ((Patrick.Wingrove@thomsonreuters.com;))