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 |
|---|---|---|---|---|---|---|---|
| Specialty Health Products CO, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
… of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are … design validation for your biocompatibility or shelf life requirements of the Class II colonic irrigation devices … or modifications to the intended use without submitting a new premarket notification to FDA as required by section … | ||||
| kdc/one Chatsworth, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | … advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your … to generate (b)(4) . Over the drug product's shelf life, (b)(4) can accumulate and increase in concentration. … of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture … | ||||
| Raaw Energy LLC | Center for Veterinary Medicine | Adulterated Animal Foods/Misbranded | … CMS # 723820 August 21, 2026 Dear Kitt Schulman, The U.S. Food and Drug Administration (FDA) conducted an … manufacturing facility located at 967 Route 524, Adelphi, New Jersey, from January 13 through January 22, 2026, … contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, a foodborne … | ||||
| Happy Farm Botanicals, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | … advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your … action for the product. Additionally, you will perform a new accelerated stability study with revised viscosity … added each year to the program to determine if the shelf-life claim remains valid Detailed definition of the specific … | ||||
| Reliance Life Sciences Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | … Reliance Life Sciences Private Limited … August 18, 2026 WARNING … advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your … Alert 66-40 on July 9, 2026. FDA may withhold approval of new applications or supplements listing your firm as a drug … | ||||
| Jabil Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | … advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your … perform a process validation study after implementing a new production step nor provide stability data within your … in your change management system before introduction of new manufacturing equipment or a new product. A summary of … | ||||
| Shoolin Pharma Chem LLP | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | … advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your … in your change management system before introduction of new manufacturing equipment or a new product. A summary of … quality criteria throughout the APIs’ assigned shelf-life. In response to this letter, provide a comprehensive, … | ||||
| TXP Innovations LLC dba Tex Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your … toxins and microorganisms that can lead to serious and life-threatening conditions. FDA Review Violations were … Water 0.9% Benzyl Alcohol (10 ml)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and … | ||||
| Royal Peptides LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your … toxins and microorganisms that can lead to serious and life-threatening conditions. FDA Review Violations were … “PT-141,” “Tesamorelin,” and “BIMORELIN” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and … | ||||
| NuScience Peptides LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your … toxins and microorganisms that can lead to serious and life-threatening conditions. FDA Review Violations were … water for Peptides (BAC Water)” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and … |