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.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Ruth Special Food Store LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| EarthLab, Inc., dba Wise Woman Herbals | Division of Human and Animal Food Operations West VI | CGMP/Dietary Supplement/Adulterated/Misbranded |
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| Big Olaf Creamery LLC dba Big Olaf | Division of Human and Animal Food Operations East IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | |||||
| Bainbridge Beverage West, LLC | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| VapeL1FE, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Mike Millenkamp Dairy Cattle | Division of Human and Animal Food Operations West II | New Animal Drug/Adulterated |
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| Empowered Diagnostics LLC | Center for Devices and Radiological Health | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |||||
| Green Pharmaceuticals Inc. | Division of Pharmaceutical Quality Operations IV | Drug Product/Adulterated |
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| RoyalVibe Health Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||||
| Land View, Inc. | Division of Human and Animal Food Operations West VI | CGMP/Medicated Feeds/Adulterated |