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 |
|---|---|---|---|---|---|---|---|
| iRhythm Technologies, Inc. | Center for Devices and Radiological Health | Medical Devices/Adulterated/Quality System Regulation (QSR) |
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| Yichang Jiayuan Foodstuffs Co., Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| ImprimisRx NJ | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products | |||||
| RemedyRepack, Inc. | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Steiner Biotechnology, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| Manzanola Feeds, LLC | Division of Human and Animal Food Operations West IV | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Mobeen Mazhar, M.D. | Center for Drug Evaluation and Research | CDER | Investigational Device Exemptions (Clinical Investigator) |
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| Mr. Lulu LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Stuff-N-Puffs 102, LLC d/b/a Stuff-N-Puffs | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| E-Juice Vapor, Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |