# Center for Drug Evaluation and Research: 604 warning letters

Updated October 30, 2026.

FDA issued 604 warning letters from the Center for Drug Evaluation and Research from November 12, 2024 to October 30, 2026, to 596 companies; 9 have a closeout letter. The newest, issued October 30, 2026 by the Center for Drug Evaluation and Research, went to RonanRx, Inc. dba RonanRx (False & Misleading Claims/Misbranded (Telehealth)).

## The full list

FDA warning letters from the Center for Drug Evaluation and Research: 604 rows for $30.20, FDA warning letters issued November 12, 2024 to October 30, 2026. Columns: Company, Issue date, Posted, Issuing office, Subject, Subject group, Response letter posted, Closeout letter posted, Read on, Source. The new rows each week by email, about 15 rows a month: $19 a month. Pay by card with no account. Prices exclude VAT. CSV and Excel files with the columns this page does not show (issue date, response letter posted, closeout letter posted and read on), which open on your screen as soon as the payment clears and come by email. The rows on this page are a sample.

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- Letters: 604
- With closeout: 9
- Latest issued: October 30, 2026

## Newest letters

The newest 100 of 604 by issue date, each linked to the letter on fda.gov.

| Issued | Company | Issuing office | Subject | Posted | Source |
| --- | --- | --- | --- | --- | --- |
| October 30, 2026 | RonanRx, Inc. dba RonanRx | Center for Drug Evaluation and Research | False & Misleading Claims/Misbranded (Telehealth) | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ronanrx-inc-dba-ronanrx-737905-10302026) |
| October 29, 2026 | Conroe Welding Supply, Inc. | Center for Drug Evaluation and Research | CGMP/Medical Gases/Adulterated | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/conroe-welding-supply-inc-731507-10292026) |
| October 27, 2026 | Pritam International Private Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pritam-international-private-limited-738079-10272026) |
| October 27, 2026 | Guangzhou Jiugong Research And Development Biotechnology Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangzhou-jiugong-research-and-development-biotechnology-co-ltd-737769-10272026) |
| October 27, 2026 | Guangdong Bisutang Biotechnology Co., Ltd. | Center for Drug Evaluation and Research | Refusal to Provide Access to and Copying of Records | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangdong-bisutang-biotechnology-co-ltd-733939-10272026) |
| October 26, 2026 | Phuoc Loc Tho Herbals, Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/phuoc-loc-tho-herbals-inc-736860-10262026) |
| October 26, 2026 | Ong Tien USA LLC | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ong-tien-usa-llc-737352-10262026) |
| October 26, 2026 | New Green Nutrition Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/new-green-nutrition-inc-737576-10262026) |
| October 26, 2026 | Natuzem | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natuzem-737558-10262026) |
| October 26, 2026 | Jing Cheong Asia Inc. dba New York Tong Ren Tang | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jing-cheong-asia-inc-dba-new-york-tong-ren-tang-738200-10262026) |
| October 26, 2026 | Guangdong Bangze Medicine Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangdong-bangze-medicine-co-ltd-734509-10262026) |
| October 26, 2026 | Bella’s Nutri Shop Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | November 3, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bellas-nutri-shop-inc-737491-10262026) |
| October 23, 2026 | Best Chinese Medicines LLC | Center for Drug Evaluation and Research | Unapproved New Drugs | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/best-chinese-medicines-llc-738556-10232026) |
| October 22, 2026 | TSP Solutions Pte. Ltd. | Center for Drug Evaluation and Research | Request for Records/CGMP/Finished Pharmaceuticals/Adulterated | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tsp-solutions-pte-ltd-735071-10222026) |
| October 22, 2026 | Sanrace Biotechnology Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sanrace-biotechnology-co-ltd-737549-10222026) |
| October 22, 2026 | Northland Nuclear Medicine, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 27, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/northland-nuclear-medicine-llc-736893-10222026) |
| October 14, 2026 | Rohto Pharmaceutical Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rohto-pharmaceutical-co-ltd-733215-10142026) |
| October 6, 2026 | Lovelace Biomedical Research Institute | Center for Drug Evaluation and Research | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lovelace-biomedical-research-institute-725136-10062026) |
| October 6, 2026 | Eurofins SF Analytical Laboratories, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eurofins-sf-analytical-laboratories-inc-736056-10062026) |
| October 5, 2026 | Silgan Dispensing Systems | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/silgan-dispensing-systems-734538-10052026) |
| October 2, 2026 | Hanlim Pharm Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hanlim-pharm-co-ltd-734782-10022026) |
| October 1, 2026 | Zhejiang Gaorong Cosmetic Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-gaorong-cosmetic-co-ltd-732511-10012026) |
| October 1, 2026 | Signature Formulations LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/signature-formulations-llc-737964-10012026) |
| October 1, 2026 | Walmart, Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/walmart-inc-736557-10012026) |
| October 1, 2026 | Terramed | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/terramed-735070-10012026) |
| October 1, 2026 | RoyceDerm LLC | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/roycederm-llc-734781-10012026) |
| October 1, 2026 | The Platinum Healthcare LLC | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/platinum-healthcare-llc-735147-10012026) |
| October 1, 2026 | OrganiCare, LLC / OrganiCare Nature’s Science, LLC | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/organicare-llc-organicare-natures-science-llc-734925-10012026) |
| October 1, 2026 | Graceful Touch, LLC | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/graceful-touch-llc-735272-10012026) |
| October 1, 2026 | DesBio/Deseret Biologicals, Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/desbiodeseret-biologicals-inc-735464-10012026) |
| October 1, 2026 | Bioactive Services USA, LLC / Herstat Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bioactive-services-usa-llc-herstat-inc-734784-10012026) |
| October 1, 2026 | Amazon.com, Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-736006-10012026) |
| October 1, 2026 | Aidance Scientific, Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aidance-scientific-inc-735346-10012026) |
| September 29, 2026 | Baxter International Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/baxter-international-inc-733231-09292026) |
| September 28, 2026 | SnugZ USA, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 20, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/snugz-usa-inc-735284-09282026) |
| September 24, 2026 | Cheap Medicine Shop/www.cheapmedicineshop.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded (Internet Pharmacy) | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cheap-medicine-shopwwwcheapmedicineshopcom-737810-09242026) |
| September 23, 2026 | Jiangmen Shuizirun Sanitary Articles Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jiangmen-shuizirun-sanitary-articles-co-ltd-722974-09232026) |
| September 23, 2026 | Online Generic Medicine/www.onlinegenericmedicine.com | Center for Drug Evaluation and Research | Unapproved New Drug/Misbranded (Internet Pharmacy) | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/online-generic-medicinewwwonlinegenericmedicinecom-737806-09232026) |
| September 22, 2026 | Fresenius Kabi USA LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 29, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresenius-kabi-usa-llc-733107-09222026) |
| September 21, 2026 | Babikian Healthcare Products CJSC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 29, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/babikian-healthcare-products-cjsc-730513-09212026) |
| September 18, 2026 | Curia New York, Inc. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | September 29, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curia-new-york-inc-728790-09182026) |
| September 18, 2026 | Empower Clinic Services, LLC dba Empower Pharmacy | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | September 22, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/empower-clinic-services-llc-dba-empower-pharmacy-738238-09182026) |
| September 17, 2026 | Bentley Laboratories LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | September 29, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bentley-laboratories-llc-732028-09172026) |
| September 14, 2026 | SCA Pharmaceuticals, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 13, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sca-pharmaceuticals-llc-724202-09142026) |
| September 14, 2026 | Celmade | Center for Drug Evaluation and Research | Review of Website/Unapproved New Drug/Misbranded | September 29, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/celmade-735876-09142026) |
| September 8, 2026 | kdc/one Chatsworth, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 22, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kdcone-chatsworth-inc-733205-09082026) |
| September 4, 2026 | Bausch & Lomb Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 15, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/bausch-lomb-inc-732398-09042026) |
| September 2, 2026 | TCI Co., Ltd BioCosme PABP BRANCH | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tci-co-ltd-biocosme-pabp-branch-736888-09022026) |
| September 1, 2026 | Happy Farm Botanicals, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 8, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/happy-farm-botanicals-inc-731926-09012026) |
| August 27, 2026 | Jabil Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jabil-inc-731037-08272026) |
| August 25, 2026 | Fresenius Medical Care AG & Co. KGaA | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresenius-medical-care-ag-co-kgaa-730319-08252026) |
| August 24, 2026 | TXP Innovations LLC dba Tex Peptides | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/txp-innovations-llc-dba-tex-peptides-735067-08242026) |
| August 24, 2026 | Royal Peptides LLC | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-peptides-llc-734884-08242026) |
| August 24, 2026 | Peptide Partners LLC | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peptide-partners-llc-735063-08242026) |
| August 24, 2026 | Peak Performance Peptides | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/peak-performance-peptides-735127-08242026) |
| August 24, 2026 | NuScience Peptides LLC | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nuscience-peptides-llc-733652-08242026) |
| August 18, 2026 | Shoolin Pharma Chem LLP | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shoolin-pharma-chem-llp-734100-08182026) |
| August 18, 2026 | Reliance Life Sciences Private Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/reliance-life-sciences-private-limited-730801-08182026) |
| August 18, 2026 | PReye, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | September 1, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/preye-llc-732141-08182026) |
| August 13, 2026 | Suretec Innovations, LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated and Misbranded | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/suretec-innovations-llc-730122-08132026) |
| August 13, 2026 | Eugia Pharma Specialities Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eugia-pharma-specialities-limited-730469-08132026) |
| August 12, 2026 | K.C. Pharmaceuticals, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/kc-pharmaceuticals-inc-729870-08122026) |
| August 12, 2026 | Auriga Research Pvt. Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/auriga-research-pvt-ltd-730694-08122026) |
| August 7, 2026 | Pine Pharmaceuticals, LLC | Center for Drug Evaluation and Research | Compounding Pharmacy/Adulterated Drug Products | October 6, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pine-pharmaceuticals-llc-728537-08072026) |
| August 7, 2026 | Safrel Pharmaceuticals LLC | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/safrel-pharmaceuticals-llc-730520-08072026) |
| August 6, 2026 | Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated/Misbranded | August 18, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tianjin-kilo-pharmaceutical-sci-tech-co-ltd-731761-08062026) |
| July 31, 2026 | FairyGene, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | August 11, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fairygene-inc-726976-07312026) |
| July 30, 2026 | Lico Industries, LLC., d.b.a. American Towelette Company | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 11, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lico-industries-llc-dba-american-towelette-company-729921-07302026) |
| July 27, 2026 | Woodbine Products Company Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/woodbine-products-company-inc-729345-07272026) |
| July 27, 2026 | Maria E. De La Torre Silva, M.D. | Center for Drug Evaluation and Research | Clinical Investigator | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/maria-e-de-la-torre-silva-md-735690-07272026) |
| July 24, 2026 | Thomas Brunner Hygiene GmbH | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/thomas-brunner-hygiene-gmbh-729018-07242026) |
| July 24, 2026 | Dabur India Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | August 4, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/dabur-india-limited-728828-07242026) |
| July 16, 2026 | Island Kinetics, Inc. d.b.a. CoValence Laboratories | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/island-kinetics-inc-dba-covalence-laboratories-726379-07162026) |
| July 13, 2026 | Shimoga Chemicals | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/shimoga-chemicals-727904-07132026) |
| July 13, 2026 | BioMylz Pvt. Ltd. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biomylz-pvt-ltd-729483-07132026) |
| July 13, 2026 | Almon Healthcare Private Limited | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/almon-healthcare-private-limited-729291-07132026) |
| July 10, 2026 | Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. | Center for Drug Evaluation and Research | In Vivo Bioavailability-Bioequivalence Studies – Clinical | July 21, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026) |
| July 8, 2026 | Spa De Soleil, Inc. | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | July 14, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/spa-de-soleil-inc-728508-07082026) |
| July 2, 2026 | International Medication Systems Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | July 14, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/international-medication-systems-limited-727560-07022026) |
| June 25, 2026 | Excelvision - Fareva | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | June 30, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/excelvision-726714-fareva) |
| June 24, 2026 | Wizcure Pharmaa Private Limited | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | June 30, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wizcure-pharmaa-private-limited-726378-06242026) |
| June 23, 2026 | Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pure-arylcyclohexylamine-store-wwwarylcyclohexylaminecom-725151-06232026) |
| June 23, 2026 | Med Shop Inc / www.medshopinc.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/med-shop-inc-wwwmedshopinccom-725157-06232026) |
| June 23, 2026 | LyfeUnit / www.lyfeunit.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lyfeunit-wwwlyfeunitcom-725156-06232026) |
| June 23, 2026 | Legit Ketamine Suppliers / www.legitketaminesuppliers.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/legit-ketamine-suppliers-wwwlegitketaminesupplierscom-725149-06232026) |
| June 23, 2026 | Ketdaxandrugs / www.ketdaxandrugs.org | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ketdaxandrugs-wwwketdaxandrugsorg-725155-06232026) |
| June 23, 2026 | ketaminetroches.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ketaminetrochescom-725148-06232026) |
| June 23, 2026 | Ketamine Troche Store / www.ketaminetrochestore.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ketamine-troche-store-wwwketaminetrochestorecom-722122-06232026) |
| June 23, 2026 | Ketamine Store / www.ketaminestore.org | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ketamine-store-wwwketaminestoreorg-725147-06232026) |
| June 23, 2026 | Ketacyn Pharmaceuticals / www.ketacynpharma.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ketacyn-pharmaceuticals-wwwketacynpharmacom-725153-06232026) |
| June 23, 2026 | Keta Med Lab / www.ketamedlab.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/keta-med-lab-wwwketamedlabcom-725154-06232026) |
| June 23, 2026 | Ket Plug / ketaminelab.org and buyketaminepowderonline.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ket-plug-ketaminelaborg-and-buyketaminepowderonlinecom-728919-06232026) |
| June 23, 2026 | Extra Medication / www.extramedication.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/extra-medication-wwwextramedicationcom-725152-06232026) |
| June 23, 2026 | Buy Keta Online / www.buyketaonline.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/buy-keta-online-wwwbuyketaonlinecom-725145-06232026) |
| June 23, 2026 | All Ketamine HCL / www.allketaminehcl.com | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | July 7, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/all-ketamine-hcl-wwwallketaminehclcom-725150-06232026) |
| June 17, 2026 | Wild Arabic Herbs | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | June 23, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wild-arabic-herbs-729192-06172026) |
| June 17, 2026 | Wholesale Peptide | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | June 23, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/wholesale-peptide-729447-06172026) |
| June 17, 2026 | Texinkart Inc. | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | June 23, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/texinkart-inc-729046-06172026) |
| June 17, 2026 | Telos Trading Limited dba Alwinshop | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | June 23, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/telos-trading-limited-dba-alwinshop-729062-06172026) |
| June 17, 2026 | MantroForce | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded | June 23, 2026 | [fda.gov](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mantroforce-729021-06172026) |

## By subject group

| Subject group | Letters | Latest |
| --- | --- | --- |
| [Unapproved drugs, marketing and online sales](https://specstream.ai/data/fda-warning-letters/subject/drug-marketing-and-online-sales) | 320 | October 30, 2026 |
| [Drug manufacturing (CGMP)](https://specstream.ai/data/fda-warning-letters/subject/drug-manufacturing) | 225 | October 29, 2026 |
| [Clinical research and labs](https://specstream.ai/data/fda-warning-letters/subject/clinical-research) | 30 | October 6, 2026 |
| [Drug compounding](https://specstream.ai/data/fda-warning-letters/subject/compounding) | 24 | August 7, 2026 |
| Other subjects | 4 | October 27, 2026 |
| [Food safety](https://specstream.ai/data/fda-warning-letters/subject/food-safety) | 1 | June 25, 2025 |

## By year issued

| Year | Letters | Latest |
| --- | --- | --- |
| [2025](https://specstream.ai/data/fda-warning-letters/year/2025) | 314 | December 30, 2025 |
| [2026](https://specstream.ai/data/fda-warning-letters/year/2026) | 266 | October 30, 2026 |
| [2024](https://specstream.ai/data/fda-warning-letters/year/2024) | 24 | December 19, 2024 |

## Where FDA publishes its warning letters

- [FDA warning letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters)

Source: [FDA warning letters (U.S. Food and Drug Administration)](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters). Public domain (U.S. government work). Letters are as FDA lists them in its warning letters table: the company, the issue and posting dates, the issuing office and FDA's subject line. Subject groups are SpecStream's, read from the words of that subject line. FDA posts a letter some weeks after it issues it, so the newest weeks fill in later.

Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).