Catalent Says It's Not Our Facility; It Belongs To Novo Nordisk
By Louis Garguilo, Chief Editor, Outsourced Pharma
The FDA informed us again in April that the Bloomington, Indiana, facilities owned by Catalent until sold to Novo Nordisk in December 2024, has not solved its quality issues.
This adds to an FDA inspection / poor response and remediation history years long in the making. (My count has it at five 483s; five VAIs; two OAI; and a Warning Letter**.)
How is it we are witnessing lingering quality issues at a facility in the middle of America first run by a name-brand CDMO and then a Big Pharma?
So does David Grote, Vice President of Strategy, GrayMatter Partners, who I turn to for some analysis on what is transpiring at this facility.
First, though, as I habitually do if parties involved have something to say that readers should hear, I print it.
Catalent in June issued this statement (in part).
“Catalent … today updated its statement to address ongoing inaccuracies in media coverage regarding the ownership of one of its former sites located in Bloomington, Indiana.
“As of December 2024, the Bloomington, Indiana site is no longer part of Catalent’s network. The site is fully owned and operated by Novo Nordisk. This followed Novo Holdings’ acquisition of Catalent in 2024 and the strategic divestiture of the Bloomington, Indiana site and two other sterile fill-finish sites to Novo Nordisk.
… reports continue to incorrectly reference the Bloomington, Indiana site as part of Catalent’s network when it is in fact owned and operated by Novo Nordisk. These references are inaccurate and outdated. While legacy naming conventions such as “Catalent Indiana” or “Catalent Indiana, LLC” may still appear in certain regulatory filings, Catalent has no ownership, operational involvement, or oversight of the site.
For clarity, the correct reference for this site is: “the Bloomington, Indiana site, fully owned and operated by Novo Nordisk.”
Fair enough.
Bloomington is Novo’s now; it’s not in Catalent’s “network.” And although the legal name of the facility, as per the FDA, is “Catalent Indiana LLC,” the media should be careful in how it describes the facility.
It’s also accurate, though, to point out the intractable quality issues at the facility stem from well before Novo purchased the facility. Novo, for its part – and understandably – is remaining quiet at this time.
Which bring us to our first point of discussion:
Did Novo Holdings, who purchased the facility for use by Novo Nordisk to produce its obesity drugs and to also continue CDMO operations, do a rigorous due diligence?
What Novo Missed In Bloomington
Grote has performed and supported pre-acquisition and pre-partnership facility assessments at organizations such as Amgen, Teva, and more recently as a consultant.
"So did Novo do its due diligence?" I ask him. There was certainly enough public information regarding Bloomington before they bought it.
Was this simply a facility Novo just had to have to manufacture its obesity drugs stateside? Did they breeze through diligence?
“Monday morning quarterbacking is easy,” Grote starts gingerly. “But it's fair to say that something was missed.”
We cannot be certain in this case, “but often due diligence activities are focused on financial aspects. Acquirers can view FDA compliance as relatively easy to deal with.”
“I suspect this diligence was more around the financial aspects related to the deal: How many batches can we make of our products? Can we operate profitably if we also continue the contract manufacturing side of the business? That’s where the focus was.”
But surely red flags were waving … recurrent particulate issues not remediated for one.
“Perhaps flagged, but not prioritized,” says Grote. “Businesses think first in terms of that financial piece. GMP operational particulars might be viewed more as costs in an overall equation. But it can be more of a tradeoff that businesses are making than they often realizing.”
“The downside of that is when quality issues occur they can be extremely expensive. If this ends up with a consent-decree type situation, you're talking perhaps billions of dollars in potential impact over years on Novo and its customers.”
How Do You Do Diligence?
One impacted customer is Regeneron, and CEO Len Schliefer has stated the Bloomington facility was involved in production of 70 million doses in the prior year for many of the top bio-pharmaceutical companies in the world.
To date we know of three Complete Response Letters (CRLs): Regeneron (odronextamab, plus Eylea HD delays); Scholar Rock (apitegromab); Incyte (Zynyz). Scholar Rock pulled apitegromab out of the site for sales in the U.S..
Did they all fail to uncover or account for issues in Bloomington?
This is the site's second OAI in ten months. The first arrived in October 2025, followed by a Warning Letter, a year of remediation, and a two-week April 2026 re-inspection by three FDA investigators. The agency then sent its second OAI.
Something to consider here: Did Catalent’s reputation put a blinder on Novo – and some customers?
“Catalent has a good reputation; I think that applies,” says Grote. “In the past I've heard professionals say, ‘Well, the FDA inspected them. We don't need to be overly concerned. They got a 483 recently, but they took care of it.’
“That should never be the attitude,” he adds. It’s never enough to rely on reputation, or good inspection history – which was definitely not the case here anyways. Sponsors need their own comprehensive due diligence.
“You need to assess what I call the quality culture and philosophy of control at each facility,” he explains. "Whether quality is designed in, and for example, understanding who has the authority to stop the production line.”
Bloomington appears to have relied on “a backend-test type of quality mentality” rather than ensuring that point-of-origin quality designs were robust.
Fortunately, particulates were found before they got to patients (as far as we know). But the contamination was generally uncovered by customers, not the CDMO initially.
“That's not the way to control things,” says Grote. “You can't control quality by testing quality in. You build it into what you do every day.”
Readers instinctually know he's talking about a fundamental shift in focus from catching to preventing mistakes, and aligning with FDA expectations for designing quality directly into operational systems and practices.
“The bottom line for me in due diligence is about the patients," Grote says. "I really wish the facility the best. I hope that the rest of the industry is paying attention, and learning from this.”
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** VAI: Voluntary Action Indicated. This means the FDA found inspection flaws, but they are not bad enough to need hard legal steps. The company fixes them on its own.
483: Form FDA 483. This is an official paper the FDA gives to a company after an inspection. It lists the conditions or practices that may break food and drug laws.
OAI: Official Action Indicated. This means the FDA found serious rule breaks during an inspection. The agency will now take strong legal or regulatory steps against the company.
Warning Letter / Official Notice: A formal letter sent directly to top company executives It demands written corrections, usually within 15 business days.
- After Form 483: If a company gives a poor response to a Form 483, the FDA escalates the issue to a Warning Letter.
- Part of OAI: Receiving a Warning Letter is one of the most common official actions taken during an OAI status.
- A Warning Letter is more serious than a Form 483 or a VAI classification.