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# FDA warning letters 2026: 502 letters issued January 1 to October 30 | SpecStream

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# FDA warning letters 2026: 502 letters issued January 1 to October 30

SpecStream

[Public data](https://specstream.ai/blog.md) · Nov 10, 2026 · 7 min read

FDA issued 502 warning letters between January 1 and October 30, 2026, to 500 companies. The same dates in 2025 had 602. The change that stands out is tobacco: letters on tobacco products fell from 206 to 46.

Drug letters went the other way. The Center for Drug Evaluation and Research issued 266, up from 251, and letters on drug manufacturing (CGMP) rose from 86 to 109.

[The FDA warning letters list](https://specstream.ai/data/fda-warning-letters?utm_source=blog&utm_campaign=fda-2026) has 1,311 rows, every letter issued from November 12, 2024 to October 30, 2026, with the company, the office, the subject and the dates. Get the first 200 rows free on the page. All 1,311 rows are $65.55, and new letters come each week by email for $19 a month.

## By issuing office

| Issuing office | 2026 | 2025 |
| --- | --- | --- |
| Center for Drug Evaluation and Research | 266 | 251 |
| Office of Inspections and Investigations | 63 | 6 |
| Human Foods Program | 49 | 40 |
| Center for Tobacco Products | 46 | 207 |
| Center for Devices and Radiological Health | 32 | 42 |
| Center for Veterinary Medicine | 22 | 13 |
| Center for Biologics Evaluation and Research | 18 | 15 |
| The Office of Prescription Drug Promotion | 2 | 2 |
| Division of Northeast Imports | 1 | 10 |
| Division of Northern Border Imports | 1 | 0 |
| Office of Compliance and Biologics Quality | 1 | 0 |
| Office of Surveillance and Compliance | 1 | 0 |
| Division of Southwest Imports | 0 | 6 |
| Division of West Coast Imports | 0 | 4 |
| Division of Southeast Imports | 0 | 3 |
| Office of Manufacturing Quality | 0 | 1 |
| ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality | 0 | 1 |
| Office of Unapproved Drugs and Labeling Compliance | 0 | 1 |

The Office of Inspections and Investigations issued 63 letters in 2026, against 6 in the same months of 2025. The Division of Northeast Imports went from 10 letters to 1, and the Southwest, West Coast and Southeast import divisions issued none in 2026.

## By subject

FDA writes a subject line on each letter. Here those lines are grouped by topic.

| Subject group | 2026 | 2025 |
| --- | --- | --- |
| Unapproved drugs, marketing and online sales | 148 | 153 |
| Drug manufacturing (CGMP) | 109 | 86 |
| Food safety | 95 | 56 |
| Tobacco products | 46 | 206 |
| Medical devices | 37 | 41 |
| Animal drugs and feed | 17 | 11 |
| Clinical research and labs | 16 | 13 |
| Dietary supplements | 11 | 11 |
| Biologics, cells and tissue | 10 | 12 |
| Drug compounding | 8 | 11 |
| Other subjects | 5 | 2 |

Unapproved drugs, marketing and online sales is the largest group in both years, 148 letters in 2026 and 153 in 2025.

## Subjects that grew

A subject counts as grown when its 2026 count is at least 1.5 times its count in the same months of 2025. Three groups pass:

-   Food safety, 95 letters against 56
-   Animal drugs and feed, 17 letters against 11
-   Other subjects, 5 letters against 2

Drug manufacturing (CGMP) rose from 86 to 109, short of that line.

## By month

| Month issued | 2026 | 2025 |
| --- | --- | --- |
| January | 36 | 26 |
| February | 59 | 36 |
| March | 49 | 72 |
| April | 58 | 62 |
| May | 50 | 58 |
| June | 89 | 53 |
| July | 41 | 62 |
| August | 43 | 51 |
| September | 33 | 129 |
| October 1 to 30 | 44 | 53 |

June was the busiest month of 2026, with 89 letters. In 2025 the peak came in September, with 129.

## The 30 newest letters

The company names and subjects are as FDA's table prints them. Each letter is in FDA's [warning letters index](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters).

| Company | Issued | Posted | Issuing office | Subject |
| --- | --- | --- | --- | --- |
| RonanRx, Inc. dba RonanRx | Oct 30 | Nov 3 | Center for Drug Evaluation and Research | False & Misleading Claims/Misbranded (Telehealth) |
| Conroe Welding Supply, Inc. | Oct 29 | Nov 3 | Center for Drug Evaluation and Research | CGMP/Medical Gases/Adulterated |
| whitedragonecigs.com | Oct 27 | Nov 3 | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Pritam International Private Limited | Oct 27 | Nov 3 | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| Guangzhou Jiugong Research And Development Biotechnology Co., Ltd. | Oct 27 | Nov 3 | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| Guangdong Bisutang Biotechnology Co., Ltd. | Oct 27 | Nov 3 | Center for Drug Evaluation and Research | Refusal to Provide Access to and Copying of Records |
| Phuoc Loc Tho Herbals, Inc. | Oct 26 | Nov 3 | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| Ong Tien USA LLC | Oct 26 | Nov 3 | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| New Green Nutrition Inc. | Oct 26 | Nov 3 | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| Natuzem | Oct 26 | Nov 3 | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| Jing Cheong Asia Inc. dba New York Tong Ren Tang | Oct 26 | Nov 3 | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| Guangdong Bangze Medicine Co., Ltd. | Oct 26 | Nov 3 | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| Bella’s Nutri Shop Inc. | Oct 26 | Nov 3 | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded |
| Best Chinese Medicines LLC | Oct 23 | Oct 27 | Center for Drug Evaluation and Research | Unapproved New Drugs |
| TSP Solutions Pte. Ltd. | Oct 22 | Oct 27 | Center for Drug Evaluation and Research | Request for Records/CGMP/Finished Pharmaceuticals/Adulterated |
| Sanrace Biotechnology Co., Ltd. | Oct 22 | Oct 27 | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| Northland Nuclear Medicine, LLC | Oct 22 | Oct 27 | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| US Tov Inc. dba US Trading Company | Oct 16 | Nov 3 | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
| Rohto Pharmaceutical Co., Ltd. | Oct 14 | Oct 20 | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
| Calibrate IV Hydration | Oct 13 | Oct 27 | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations |
| snuskompagniet.com | Oct 8 | Oct 20 | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| snusi.net | Oct 8 | Oct 20 | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
| Olympus Medical Systems Corporation | Oct 7 | Oct 20 | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| Tides Medical LLC | Oct 6 | Oct 20 | Center for Biologics Evaluation and Research | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Lovelace Biomedical Research Institute | Oct 6 | Oct 13 | Center for Drug Evaluation and Research | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
| Eurofins SF Analytical Laboratories, Inc. | Oct 6 | Oct 13 | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated |
| Pro-Optics, LLC | Oct 5 | Oct 27 | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
| Silgan Dispensing Systems | Oct 5 | Oct 13 | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Chirp Innovations, LLC | Oct 2 | Oct 27 | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
| originalc.co.uk | Oct 2 | Oct 13 | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |

The four tobacco letters in this table are addressed to websites, such as whitedragonecigs.com and snusi.net. Six letters issued October 26, 2026 carry the subject Unapproved New Drugs/Misbranded.

## Companies with more than one letter in 2026

Two companies received two letters each this year. Amazon.com, Inc. received letters issued June 17 and October 1, 2026. Signature Formulations, printed as both Signature Formulations LLC and Signature Formulations, LLC, received letters issued January 21 and October 1, 2026.

## How to read these numbers

The letters come from FDA's warning letters table. Each letter has an issue date and a later posting date; the counts here use the issue date. The window is January 1 to October 30, 2026, the newest issue date held, and the newest posting is November 3, 2026. The 2025 figures cover January 1 to October 30, 2025.

A warning letter is FDA's notice of what it found. The company can respond, and FDA can later post a closeout letter. Of the letters issued in 2026, 6 have a closeout letter posted so far.

The table names no country or state, so there is no count by place. One letter addressed to a named person, issued January 9, 2026, is left out of every count and list here.

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