FOIAengine: Fresenius Companies Targeted in 65 FOIA Requests
Fresenius SE & Co. KGaA (FRE GR), the German healthcare group, and its affiliates were targeted by a major wave of Freedom of Information Act requests to the Food and Drug Administration in the first nine months of this year.
The FOIA requests from law firms (16 requests), financial firms, (eight), and research organizations (41) sought details about the FDA’s eight manufacturing plant inspections this year in the United States, Germany and Colombia.
The requests are significant because they represent concentrated FDA FOIA activity from dozens of requesters targeting a single company. We track the requests in FOIAengine, which compiles FOIA requests to 47 federal agencies in as close to real time as availability allows. FOIA requests can signal coming stock price movements, litigation, news stories, or other business activity.
Publicly traded Fresenius SE, based in Bad Homburg, has evolved through acquisitions and expansion into one of Europe’s largest healthcare businesses. Its two wholly-owned divisions are Fresenius Kabi, which manufactures injectable generic drugs and medical technology, and Fresenius Helios, which operates hospitals and outpatient healthcare facilities, primarily in Europe. Fresenius also retains a stake of about 25 percent in separately listed Fresenius Medical Care, one of the world’s largest providers of kidney dialysis services and equipment.
Fresenius Kabi and Fresenius Medical Care operate dozens of manufacturing sites around the world that are subject to FDA regulation. Kabi has three U.S. facilities and international operations in Germany, China, India, Italy, Portugal, Brazil, Mexico. Fresenius Medical Care operates 35 production sites worldwide and two facilities in the U.S.
With their significant U.S. manufacturing and sales, both companies are actively regulated and monitored by the FDA. The companies have been subject to numerous plant inspections resulting in documents that investors, litigators, reporters and others want to see.
Through the first nine months of 2026, 65 FOIA requests were filed with the FDA seeking documents about the agency’s inspections and enforcement actions relating to five domestic and three international manufacturing facilities in Wilson, NC (eight); Melrose Park, IL (10); Ogden, Utah (seven); Grand Island, NY (five); Waltham, MA (eight); Germany (three); and Cota, Columbia (five).
The large number of Fresenius-related requests so far this year stands in contrast to the trend from the past twelve years.
This year’s requests were submitted by five law firms (Kelley Drye & Warren LLP; Levin Papantonio, MLP LLP, Reddick Law, and Smith Clinesmith LLP); five financial firms (BNP Paribas, Citi, Bank of America, Jefferies and UBS); and three research firms (Redica Systems, FOIA Professional Services, and Clarivate Analytics).
Most requests sought one or two plant inspection reports. For example, on May 26, Kareen Ejoh of Kelley Drye & Warren, LLP wrote: “Please provide us with all Form 483’s received by Fresenius USA Manufacturing, Inc. based in Ogden, Utah since 01-Jun-2025 to 26-May-2026.” A Form 483 is a report issued by FDA investigators at the conclusion of a facility inspection to document conditions or practices that may violate FDA law.
Other requests were more ambitious. On September 3, Giang H. Nguyen of Citi wrote: “I am seeking inspection records for all the facilities in the United States and outside of the United States of Fresenius Medical Care, this should include Forms 483 (Notice of Inspectional Observations). Fresenius Medical Care as of year-end 2025 runs 35 production sites in 19 countries, including 8 in the US (incl. Ogden Utah, Waltham), 3 in S America (incl. Reynosa Mexico), 18 in Europe (incl. St. Wendel Germany, L’Arbresle France, Schweinfurt Germany), 4 in Asia (incl. Changshu China, Buzen Japan), and 2 in Australia. Return results for all 35 production sites.”
Historical Requests Compared to Current Year
Beginning in 2015, FOIA requests about Fresenius grew from eight in that year to 32 in 2020 and 65 thus far in 2026. Altogether, 291 FOIA requests were submitted seeking information about Fresenius companies during the 12-year period.
Historically, the leading topics were Form 483 inspection observations (149 requests), Establishment Inspection Reports (97), drug and biologic application and approval files (54), FDA correspondence and communications (45), medical device clearance submissions (19), corporate filings and agreements (17), FDA warning letters (13), and drug labeling issues (11).
Requests shifted over this period toward a much stronger emphasis on manufacturing inspections and regulatory compliance. Requests for FDA Form 483 inspection observations were consistently important throughout the period, but increased dramatically in 2026, reaching 52 requests compared with just 10 in 2025 and 9 in 2024.
Not included in the number above were scores of requests submitted by Fresenius itself — 140 requests in all, including 22 for documents relating to its own companies.
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Next: The latest FOIA requests to the Securities and Exchange Commission and the Federal Trade Commission.
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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.