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 |
|---|---|---|---|---|---|---|---|
| Premium Health Management Inc. dba Premium Health | Center for Drug Evaluation and Research (CDER) | Failure to Register and List/Misbranded |
|||||
| Kare Solutions, LLC dba Zappy | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | |||||
| Strut Health, LLC dba Strut | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | |||||
| Peaks Curative, LLC dba Peaks | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | |||||
| Lean Rx, Inc. dba SkinnyRx | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | |||||
| Good Girl LLC dba GoodGirlRX | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | |||||
| Refills Health, LLC dba Refills Health | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | |||||
| PharmaZee | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | |||||
| Weightless Medical LLC dba WeightCare | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded | |||||
| Ivim Services LLC dba Ivim | Center for Drug Evaluation and Research (CDER) | False & Misleading Claims/Misbranded |