FOIAengine: Warning Letters and Inspection Reports in the Spotlight
Freedom of Information Act requests filed with the Food and Drug Administration by hedge funds last month revealed big financial players closely eyeing warning letters, enforcement documents, and inspection reports for major drug manufacturers and biopharma companies.
At the forefront was a sweeping request from Greenwich, Conn.-based Deep Track Capital for all Form 483 inspection reports issued by the FDA over nearly three years to two companies – CG Oncology (NASDAQ: CGON), which develops immunotherapies for bladder cancer; and Biovire, a contract manufacturer specializing in the final step of packaging “novel drugs and medical devices” for patient use.
Deep Track, focused exclusively on the life sciences industry, has $5.2 billion in assets under management and invests in public and pre-IPO biotechnology companies. Form 483 reports, which the hedge fund is seeking, describe plant-inspection observations made by the FDA.
At PoliScio Analytics, our FOIAengine database tracks FOIA requests in as close to real-time as their availability allows. We treat FOIA requests to the federal government as signals. Deep Track has 13 requests listed in FOIAengine, going back to September 2022. Deep Track’s most recent FOIA request stands out because it likely presaged either a contemplated investment, or an analyst’s deeper dive to uncover operational insights.
Notably, neither CG Oncology nor Biovire appeared in the most recent available (Q3 2025) Securities and Exchange Commission 13F report of Deep Track’s holdings. But within days following Deep Track’s December 29 FOIA request, CG Oncology made a major announcement about positive results from a Phase 3 clinical trial. The share price of CG Oncology jumped nearly 30 percent that day – January 9 – on unusually high volume of seven million shares, roughly seven times the daily norm. The big stock-price jump produced a one-year return of about 366 percent for CGON investors who held the stock for the full year.
Biovire, the other company that was the subject of Deep Track’s December 29 FOIA request, is a private concern. But it has at least one connection to publicly-traded CG Oncology: In a 10-Q filing last May 13, CG Oncology disclosed that its wholly-owned subsidiary, SafeGuard Healthcare, made a $25 million investment in Biovire so that Biovire could acquire assets related to manufacturing CG Oncology’s products.
The FDA didn’t provide the name of the Deep Track analyst making the request.
In addition to the FOIA request by Deep Track, the FDA received noteworthy requests last month from financial players that included Point72, Exodus Point, Rising Pharma Holdings, J.P. Morgan, Truist Securities, Actua Capital, Piper Sandler, Royalty Pharma, Jefferies International, Iron Triangle Partners, and Triple Gate Capital. The requests fell into three categories: inspections and compliance (Form 483 reports); targeted requests for enforcement actions and warning letters at large contract manufacturers like Catalent and Lonza; and drug and device recall data. Subscribers have access to all the requests. Highlights follow:
Iron Triangle analyst Conor Hogan on December 17 requested “all Form 483s, observations, warning letters, or FDA notifications regarding the Vacaville, California drug manufacturing site currently owned by Lonza Group AG (site was previously owned by Roche Holding AG).” Hogan’s request relates to adverse findings during a September 29 FDA inspection of the Lonza facility. Lonza Group AG is a Swiss multinational company in the pharmaceutical and biotech contract manufacturing space — including biologics production and custom pharma manufacturing. It is publicly listed on the SIX Swiss Exchange, and its stock is part of Swiss market indexes.
Exodus Point also sought records about Lonza. It’s December 13 FOIA request sought “Form 483 inspection materials for the inspection conducted on 08/22/2025 for Lonza Tampa, LLC, located at Tampa, FL.”
Complementing the compliance data requests were FOIA requests aimed at recall lists for sterile injectables and specific adverse-event narratives – including documents tied to serious ocular outcomes.
Among the Point 72 requests were two filed on December 2 and 4 by Caroline Kubicki and Marissa Conte, respectively. Kubicki sought “the warning letter issued to Catalent in November of 2025.” The Catalent warning came in an FDA letter to the company on November 20. The FDA found significant violations, including inadequate investigations into batch failures and contamination issues (including extrinsic particles like mammalian hair), failure to implement effective corrective actions, and other lapses that could render products adulterated under the Food, Drug, and Cosmetic Act.
Drug-manufacturer Catalent, once an NYSE-listed company, was acquired by Novo Holdings, an investment company responsible for managing the assets and the wealth of the Novo Nordisk Foundation, in December 2024. The acquisition was an all-cash transaction with a total enterprise value of approximately $16.5 billion.
Triple Gate Capital’s Norbert Gottesman also sought records about Catalent. In the first of two December 12 requests, Gottesman sought “all written communications from FEI 3005949964 to the FDA since August 1, 2025; including but not limited to the 15-day Inspection Response letter and all subsequent correspondence.” FEI stands for Facility Establishment Identifier, a unique code assigned to a specific manufacturing site. The identifier in question belongs to Catalent.
Gottesman’s other request sought “a list of sterile injectable prescriptions drugs which have been subject to recalls in the US since September 1, 2025.” Sterile injectable recalls continue to draw headlines for supply risk and patient safety,
Meanwhile, Point72’s Conte asked for “any agency documentation regarding the Form 483 (FEI 3001675293) issued to Intuitive Surgical, Inc.” (NASDAQ:ISRG) in Sunnyvale, Cal. With over $10 billion in annual revenue, the medical equipment maker’s stock has been on a tear for the past year, and Intuitive is one of Point72’s biggest holdings. Point72’s most recent Form 13F valued the hedge fund’s Intuitive holdings at $275 million.
Intuitive previously had FDA inspection issues. A 2013 inspection report listed multiple violations at Intuitive’s Sunnyvale facility. Point72 now appears to be trying to update the FDA’s inspection write-ups, along with the company’s responses. The primary-source documents could reveal quality-system or manufacturing-control issues before they surface in enforcement actions or public disclosures.
Taken together, the FOIA filings provide a roadmap to emerging regulatory and manufacturing pressures – before they become public enforcement actions, product shortages, or narrative-driven safety stories. Whether it’s a biotech company under repeated inspection scrutiny or a global contract manufacturer’s compliance arc, the requests signal where the next regulatory story may already be taking shape.
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John A. Jenkins, co-creator of FOIAengine, is a Washington journalist and publisher whose work has appeared in The New York Times Magazine, GQ, and elsewhere. He is a four-time recipient of the American Bar Association’s Gavel Award Certificate of Merit for his legal reporting and analysis. He is the author, most recently, of The Partisan: The Life of William Rehnquist, and the forthcoming Summer of ’71, about fateful events in the year before Watergate. Jenkins founded Law Street Media in 2013. Prior to that, he was President of CQ Press, the textbook and reference publishing enterprise of Congressional Quarterly. FOIAengine is a product of PoliScio Analytics (PoliScio.com), a new venture specializing in U.S. political and governmental research, co-founded by Jenkins and Washington lawyer Randy Miller. Learn more about FOIAengine here. To review FOIA requests mentioned in this article, subscribe to FOIAengine.
Write to John A. Jenkins at JAJ@PoliScio.com.