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 |
|---|---|---|---|---|---|---|---|
| Blue Horizon International, LLC | Center for Biologics Evaluation and Research (CBER) | Unapproved New Drugs/Unlicensed Biological Product Violations | … Endocrine Diseases, including Hashimoto’s thyroiditis and Hypothyroidism o Musculoskeletal Diseases, including … | ||||
| Swift Digital Group LLC dba Swadesii | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs | … o In the name of the product – “Thyroid Tablet” o “Hypothyroidism o Helps in activating thyroid glands” … | ||||
| Ambaya Gold Health Products, LLC | Division of Human and Animal Food Operations West IV | Unapproved New Drugs/Misbranded | |||||
| ALI Pharmaceutical Manufacturing, LLC | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | … you manufactured is used to produce drug products to treat hypothyroidism. Because of the narrow therapeutic range of … | ||||
| Moorish Science Temple, The Divine and National Movement of North America, Inc; #13 The Moorish American National Republic dba Moor Herbs, Inc. | Division of Human and Animal Food Operations East VI | Unapproved New Drugs/Misbranded | … (also referred to as “HyperThyroid Support”), “HypoThyroidism” (also referred to as “HypoThyroid Support”), … such as agitation, restlessness, sweating and insomnia.” “HypoThyroidism” (also referred to as “HypoThyroid Support”) On the “HypoThyroidism” product webpage of your website … | ||||
| Hekma Center, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drugs/Dietary Supplements/Food Labeling/Misbranded |
… To balance thyroid gland functioning especially in case of Hypothyroidism . . . 6. . . . It also alleviates blood … | ||||
| Sovereign Pharmaceuticals, LLC | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated | … it is especially important to prevent patients with hypothyroidism from receiving insufficient or excessive … | ||||
| Specialty Process Labs LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | … you manufactured is used to produce drug products to treat hypothyroidism. Because of the narrow therapeutic range of … | ||||
| ICA Health, LLC/Future Formulations, LLC | Office of Human and Animal Foods Operations – Division West 4 | New Drug/Misbranded |
… and increase in reverse T3 in your cells results in tissue hypothyroidism that is not detected in standard thyroid … | ||||
| Groupe Cyrenne Inc. dba HomeoAnimal | Center for Veterinary Medicine | Unapproved New Animal Drug Products | … “Helps correct thyroid imbalances for pets suffering from hypothyroidism or hyperthyroidism…” • Virus Defense Kit • On … |