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 |
|---|---|---|---|---|---|---|---|
| Sante Manufacturing Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Maximus Health, Inc. dba Maximus | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
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| Trinity HealthCare Supply, LLC dba altRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
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| Glow Medispa, LLC dba Mint Med | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) |
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| Ezra Holdco LLC dba Ezra | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | |||||
| Public Health Solution LLC dba DrMedHealth | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded (Telehealth) | |||||
| M G R Produce LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Pharmathen International S.A. | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| YS Group Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| ZOLL Medical Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |