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 |
|---|---|---|---|---|---|---|---|
| Sprout Health Partners LLC dba Sprout Health | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) | … Sprout Health Partners LLC dba Sprout Health … WARNING LETTER September 9, 2025 Sprout … | ||||
| Rhodes Legacy Inc DBA Sun Sprouts | Division of Human and Animal Food Operations West II | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
… Disease Control and Prevention (CDC) and state and local partners, investigated a multistate outbreak of Salmonella … on our inspectional findings, we have determined that your sprout products are adulterated within the meaning of section … filth or whereby they may have been rendered injurious to health. In addition, failure to comply with the PSR … |