Warning Letters
Learn about the types of warning letters on FDA's website.
- Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
- To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc. | Center for Drug Evaluation and Research (CDER) | Postmarketing Adverse Drug Experience Reporting Requirements | … Novo Nordisk Inc. … WARNING LETTER Mr. David S. Moore FDA Ref. No.: 26-HFD-45-03-01 President Novo Nordisk Inc. 800 Scudders Mill Road Plainsboro, New Jersey … | ||||
| Catalent Indiana, LLC | Office of Manufacturing Quality | CGMP/Finished Pharmaceuticals/Adulterated | … in drug products they received from you. Since Novo Nordisk acquired this facility, at least (b)(4) batches of … mammalian hair contamination events, we are concerned that Novo Nordisk released batches in which your customers found … | ||||
| Eli Lilly and Company | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … two global pharmaceutical companies behind these meds, Novo Nordisk and Eli Lilly appearing together here for the first … are here. Negelle Morris is a senior vice president for Novo Nordisk, the Danish company behind Ozempic and Wegovy, … | ||||
| Novo Nordisk Inc. | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | … two global pharmaceutical companies behind these meds, Novo Nordisk and Eli Lilly appearing together here for the first … are here. Negelle Morris is a senior vice president for Novo Nordisk, the Danish company behind Ozempic and Wegovy, … | ||||
| www.dashpct.com | Center for Drug Evaluation and Research | CDER | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet | … “Rybelsus 14mg” and “Rybelsus 7mg” tablets manufactured by Novo Nordisk and offered by www.dashpct.com. Currently, other than … |