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 |
|---|---|---|---|---|---|---|---|
| MantroForce | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
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| Great India Overseas Pvt. Ltd. dba Silkrute | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | |||||
| Leading Edge Health Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Indiangoods.shop | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
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| Wild Arabic Herbs | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Texinkart Inc. | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
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| Hadassah Healing Oils Ltd | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | |||||
| Huons Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Imu-Tek Animal Health, Incorporated | Human Foods Program | Dietary Supplement/New Drug/Misbranded |
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| Vivot LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |