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 |
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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 | |||||
Ruth Special Food Store LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
Empowered Diagnostics LLC | Center for Devices and Radiological Health | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) | |||||
RoyalVibe Health Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded | |||||
Bainbridge Beverage West, LLC | Division of Human and Animal Food Operations West V | Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
Land View, Inc. | Division of Human and Animal Food Operations West VI | CGMP/Medicated Feeds/Adulterated | |||||
Green Pharmaceuticals Inc. | Division of Pharmaceutical Quality Operations IV | Drug Product/Adulterated |
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MD Pharmaceutical Supply, LLC | Division of Pharmaceutical Quality Operations I | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
VapeL1FE, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |