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 |
|---|---|---|---|---|---|---|---|
| Prime Sciences | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet | |||||
| Ehsan Sadri, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | |||||
| Lovega LLC dba Pink Pony Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet | |||||
| Gram Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet | |||||
| Global Tobacco, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Life Plus Style Gourmet LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| FormPour | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
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| Guangzhou Huli Technology Co., Ltd. dba Fantasy Face | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet | |||||
| Mile High Compounds LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs Sold Over the Internet |
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| Medline Industries, LP | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |