FOIAengine: Catalent Targeted by 259 FOIA Requests Since 2020
Wall Street got unusually curious last month about the safety records at one pharmaceutical factory.
Five investment firms were among those filing Freedom of Information Act requests seeking Food and Drug Administration inspection records about drug maker Catalent’s Bloomington, Indiana facility – a site whose recurring quality lapses threaten to turn Novo Nordisk’s $16.5 billion-dollar purchase into a costly liability.
The FOIA requests signaled efforts by the investment firms to use FOIA to gain a trading edge as Catalent experienced repeated run-ins with the Food and Drug Administration over plant safety and quality violations, according to a PoliScio Analytics analysis.
Catalent, which was acquired by Novo Nordisk in December, is a leading contract drug manufacturer operating over 30 manufacturing facilities in the U.S. and abroad. The company makes hundreds of products ranging from blockbuster GLP-1 weight loss drugs to Covid 19 vaccines.
A July FDA inspection of Catalent’s Indiana facility found that the plant failed to properly investigate “atypical extrinsic particles” that included cat hair and human hair in vial stoppers, plus pests and bacterial contamination in manufacturing areas. During an October reinspection, the facility was classified “OAI” (Official Action Indicated) by FDA – the most serious of its three inspection classifications, signaling that regulatory or enforcement action is on the table.
That triggered Wall Street’s FOIA scrutiny of Catalent.
In just-released October FOIA requests to the FDA, the U.S. investment firms sought a range of additional compliance documents relating to Catalent. These included inspection reports; communications with FDA staff regarding remediation efforts; planned reinspections; and anticipated enforcement actions. Requests were submitted by TD Cowen, Logos Capital Management, Ashler Capital, Evercore ISI, and Orbis Portfolio Management. Details of the requests are presented at the end of this article.
The FOIA requests were among those just added to PoliScio Analytics’ competitive-intelligence database FOIAengine, which tracks FOIA requests in as close to real-time as their availability allows.
Trouble Magnet: According to FOIAengine, since 2020 Catalent has been the subject of 259 FOIA requests, with 110 (42 percent) requests targeting the Bloomington plant. This high percentage is particularly notable given Catalent’s large number of global facilities. Moreover, the plant is targeted by every category of FOIA requester, including financial firms, news media, corporations, law firms, and research companies. And the scrutiny has been consistent over the past five years.
Two other Catalent plants have been the subject of dozens of other FOIA requests: its gene therapy plant in Harmans, Maryland (45 requests) and its Wegovy plant in Brussels, Belgium (38 requests). Together with Bloomington, the three plants account for 75 percent of all Catalent-related requests.
The FOIAengine analysis reveals that Catalent’s regulatory and business risk is surprisingly site-specific. At least three major drugs (Eylea HD, odronextamab, and apitegromab) have seen FDA decisions delayed or rejected primarily because of inspection findings at Catalent’s Bloomington plant. And in 2022, Moderna’s Covid 19 vaccine production in Bloomington was delayed by the FDA due to quality control issues and the failure to establish and follow procedures.
The FOIA requests also reveal how hedge funds and investment firms use FOIA requests to inform their investment decisions. Since 2020, 27 different financial organizations have submitted a total of 63 requests targeting Catalent. A review of the requests reveals that investors repeatedly ask for records about a single site. Requesters appear to target specific date windows and make requests when specific sites are likely tied to market-moving events like product approvals, supply constraints, and mergers and acquisitions. The timing of requests is indicative of the sophisticated regulatory-intelligence workflow inside some hedge funds.
Following are excerpts from the October FOIA requests to the FDA targeting Catalent’s Bloomington, Indiana plant:
- Marc Frahm of TD Cowen filed a request on October 15 seeking “all EIR, form 483s, and correspondence and communications regarding NAI/VAI/OAI classifications regarding Catalent/Novo Holdings’ facility in Bloomington, Indiana. We are also seeking records of any other correspondence or communications between the FDA and Catalent/Novo regarding remediation efforts, any planned or conducted reinspections of the facility, or anticipated enforcement actions including warning letters involving the Catalent facility in Bloomington, Indiana. Given the importance of Catalent’s Bloomington facility to the overall U.S. biologic drug supply, we are also seeking records of any other correspondence or communications within the FDA regarding remediation efforts, any planned or conducted reinspections of the facility, or anticipated enforcement actions including warning letters involving the Catalent facility in Bloomington, Indiana.”
- Dennis Holl filed a request on October 15 asking for “the FDA inspection classification letter issued on October 9, 2025, to Catalent Indiana, LLC, Bloomington, IN” and for “any related inspectional documentation, including Form FDA 483 and the Establishment Inspection Report (EIR) for the inspection conducted from June 23, 2025, through July 14, 2025, classified as Official Action Indicated (OAI).” The FDA didn’t further identify Holl’s affiliation.
- Brandon Adams of Logos Capital Management on October 16 filed a request seeking “all records issued or generated in 2025 concerning regulatory compliance actions at the Catalent Indiana (Bloomington) facility, specifically including any of the following: Voluntary Action Indicated (VAI) letters, No Action Indicated (NAI) letters, and Official Action Indicated (OAI) letters. Additionally, please provide all inspectional records and correspondence such as Form 483s, Establishment Inspection Reports (EIRs), warning letters, or other formal findings exchanged between the FDA and Catalent in 2025 relating to this site. I also request copies of all communications (including emails, letters, memos, meeting notes, or other written exchanges) during 2025 between the FDA and Catalent, as well as the FDA and Scholar Rock, that reference facility observations, compliance status, or regulatory actions relevant to the Catalent, Indiana, or Bloomington facility. Please include any complete response letters (CRLs), decision letters, or similar notifications directed to Scholar Rock for applications involving Apitegromab.”
- Amy Guo of Ashler Capital on October 16 requested “the inspection record of Catalent, Indiana’s Bloomington site (FEI 3005949964) and corresponding EIR & form 483 of the inspection.”
- Joshua Chazaro of Evercore ISI requested on October 15 “records of FDA inspections at Catalent Indiana, Bloomington (FEI 3005949964) Jan 1, 2024–present: (1) all 483s, EIRs (+attachments), and 483 responses; (2) inspection classifications, Warning/Untitled & close-out letters; (3) FDA correspondence with Catalent/Scholar Rock/Regeneron observations, CAPAs, lot disposition/holds, or supply disruption; (4) FARs/BPDRs/recalls citing this FEI; (5) compliance/decision/risk memos on severity; (6) list of inspections with dates & classifications.
- Giacomo Gibello of Orbis Portfolio Management on October 15 sought “records related to the July 14, 2025 FDA inspection of Catalent Indiana LLC (now Novo Nordisk) in Bloomington, IN (FEI: 3005949964).
A Form 483 is issued to firm management at the conclusion of an inspection when investigators have observed conditions that may constitute violations of the Food Drug and Cosmetic Act. An Establishment Inspection Report (EIR) is generated after FDA investigators inspect facilities involved in manufacturing, processing, or distributing FDA-regulated goods. Following an inspection, the FDA evaluates the findings to determine if the facility is in compliance with applicable laws and regulations and classifies the inspection, and then classifies the findings as No action indicated (NAI), Voluntary action indicated (VAI), Official action indicated (OAI), which means regulatory and/or administrative actions are recommended.
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Randy E. Miller, co-creator of FOIAengine, is a Washington lawyer, publisher, and former government official. He has developed several online information products and was a partner at Hogan Lovells, where he founded the firm’s Brussels office and represented clients on international regulatory matters. Miller also has served as a White House trade lawyer, Senior Legal Adviser to the U.S. Mission to the World Trade Organization, policy director to Senator Bob Dole, and adjunct professor at Georgetown University. He is a graduate of Yale and Georgetown Law. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a venture specializing in U.S. political and governmental research, co-founded by Miller and Washington journalist John A. Jenkins. Write to Randy E. Miller at randy@poliscio.com.
