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Data / FDA warning letters

FDA warning letters: 1,311 issued since Nov 2024

The full list. FDA warning letters: 1,311 rows for $65.55, FDA warning letters issued November 12, 2024 to October 30, 2026. The list gains about 39 rows a month. The new rows come each week by email, $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 weekly rows run until you cancel, from the link in each delivery. The rows on this page are a sample.

For agents and scripts: this list is ordered at https://specstream.ai/data/fda-warning-letters, and every list with its row count and price is at https://specstream.ai/data/lists.json.

Updated October 30, 2026. Source: FDA warning letters (U.S. Food and Drug Administration).

FDA issued 1,311 warning letters from November 12, 2024 to October 30, 2026, to 1,275 companies; 40 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 request: Every new FDA warning letter on drug manufacturing (CGMP), with the company, the office and the letter. $10 of credit on sign-up, no card.

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  • 1,311Letters
  • 40With closeout
  • October 30, 2026Latest issued

Newest letters

The newest 100 of 1,311 by issue date, each linked to the letter on fda.gov.

IssuedCompanyIssuing officeSubjectPostedSource
October 30, 2026RonanRx, Inc. dba RonanRxCenter for Drug Evaluation and ResearchFalse & Misleading Claims/Misbranded (Telehealth)November 3, 2026fda.gov
October 29, 2026Conroe Welding Supply, Inc.Center for Drug Evaluation and ResearchCGMP/Medical Gases/AdulteratedNovember 3, 2026fda.gov
October 27, 2026whitedragonecigs.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNovember 3, 2026fda.gov
October 27, 2026Pritam International Private LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNovember 3, 2026fda.gov
October 27, 2026Guangzhou Jiugong Research And Development Biotechnology Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNovember 3, 2026fda.gov
October 27, 2026Guangdong Bisutang Biotechnology Co., Ltd.Center for Drug Evaluation and ResearchRefusal to Provide Access to and Copying of RecordsNovember 3, 2026fda.gov
October 26, 2026Phuoc Loc Tho Herbals, Inc.Center for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedNovember 3, 2026fda.gov
October 26, 2026Ong Tien USA LLCCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedNovember 3, 2026fda.gov
October 26, 2026New Green Nutrition Inc.Center for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedNovember 3, 2026fda.gov
October 26, 2026NatuzemCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedNovember 3, 2026fda.gov
October 26, 2026Jing Cheong Asia Inc. dba New York Tong Ren TangCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedNovember 3, 2026fda.gov
October 26, 2026Guangdong Bangze Medicine Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNovember 3, 2026fda.gov
October 26, 2026Bella’s Nutri Shop Inc.Center for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedNovember 3, 2026fda.gov
October 23, 2026Best Chinese Medicines LLCCenter for Drug Evaluation and ResearchUnapproved New DrugsOctober 27, 2026fda.gov
October 22, 2026TSP Solutions Pte. Ltd.Center for Drug Evaluation and ResearchRequest for Records/CGMP/Finished Pharmaceuticals/AdulteratedOctober 27, 2026fda.gov
October 22, 2026Sanrace Biotechnology Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 27, 2026fda.gov
October 22, 2026Northland Nuclear Medicine, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 27, 2026fda.gov
October 16, 2026US Tov Inc. dba US Trading CompanyOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)November 3, 2026fda.gov
October 14, 2026Rohto Pharmaceutical Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedOctober 20, 2026fda.gov
October 13, 2026Calibrate IV HydrationCenter for Biologics Evaluation and ResearchUnapproved New Drugs/Unlicensed Biological Product ViolationsOctober 27, 2026fda.gov
October 8, 2026snuskompagniet.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedOctober 20, 2026fda.gov
October 8, 2026snusi.netCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedOctober 20, 2026fda.gov
October 7, 2026Olympus Medical Systems CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedOctober 20, 2026fda.gov
October 6, 2026Tides Medical LLCCenter for Biologics Evaluation and ResearchInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA)October 20, 2026fda.gov
October 6, 2026Lovelace Biomedical Research InstituteCenter for Drug Evaluation and ResearchGood Laboratory Practice (GLP) for Nonclinical Laboratory StudiesOctober 13, 2026fda.gov
October 6, 2026Eurofins SF Analytical Laboratories, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 13, 2026fda.gov
October 5, 2026Pro-Optics, LLCCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA)October 27, 2026fda.gov
October 5, 2026Silgan Dispensing SystemsCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugOctober 13, 2026fda.gov
October 2, 2026Chirp Innovations, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedOctober 27, 2026fda.gov
October 2, 2026originalc.co.ukCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedOctober 13, 2026fda.gov
October 2, 2026John & Nicole Santos DairyCenter for Veterinary MedicineNew Animal Drug/AdulteratedOctober 13, 2026fda.gov
October 2, 2026Hanlim Pharm Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 13, 2026fda.gov
October 1, 2026Zhejiang Gaorong Cosmetic Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 2026fda.gov
October 1, 2026Signature Formulations LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 2026fda.gov
October 1, 2026Walmart, Inc.Center for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
October 1, 2026TerramedCenter for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
October 1, 2026RoyceDerm LLCCenter for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
October 1, 2026The Platinum Healthcare LLCCenter for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
October 1, 2026OrganiCare, LLC / OrganiCare Nature’s Science, LLCCenter for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
October 1, 2026Graceful Touch, LLCCenter for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
October 1, 2026DesBio/Deseret Biologicals, Inc.Center for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
October 1, 2026Bioactive Services USA, LLC / Herstat Inc.Center for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
October 1, 2026Amazon.com, Inc.Center for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
October 1, 2026Aidance Scientific, Inc.Center for Drug Evaluation and ResearchUnapproved New DrugsOctober 6, 2026fda.gov
September 29, 2026IF Co-Pack, LLC dba Initiative FoodsHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/AdulteratedNovember 3, 2026fda.gov
September 29, 2026Psyched Wellness Ltd.Human Foods ProgramDietary Supplement/AdulteratedOctober 20, 2026fda.gov
September 29, 2026Baxter International Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 2026fda.gov
September 29, 2026Dreyer’s Grand Ice Cream, Inc.Human Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedOctober 13, 2026fda.gov
September 28, 2026SnugZ USA, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 2026fda.gov
September 25, 2026Beaute BountyCenter for Biologics Evaluation and ResearchUnapproved New Drugs/Unlicensed Biological Product ViolationsOctober 27, 2026fda.gov
September 25, 2026sfshoply.comCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedSeptember 29, 2026fda.gov
September 24, 2026Cheap Medicine Shop/www.cheapmedicineshop.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/Misbranded (Internet Pharmacy)October 6, 2026fda.gov
September 23, 2026Jiangmen Shuizirun Sanitary Articles Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 13, 2026fda.gov
September 23, 2026Online Generic Medicine/www.onlinegenericmedicine.comCenter for Drug Evaluation and ResearchUnapproved New Drug/Misbranded (Internet Pharmacy)October 6, 2026fda.gov
September 23, 2026Sciarra Aeromed, Inc.Center for Veterinary MedicineCGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedSeptember 29, 2026fda.gov
September 23, 2026Neogen CorporationCenter for Veterinary MedicineCGMP/Drugs for Animals/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedSeptember 29, 2026fda.gov
September 22, 2026Rama Food Manufacture Corp.Human Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenesOctober 27, 2026fda.gov
September 22, 2026Datil Fresh Produce LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)October 13, 2026fda.gov
September 22, 2026Unilam Co., LTDCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedOctober 6, 2026fda.gov
September 22, 2026Fresenius Kabi USA LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 29, 2026fda.gov
September 21, 2026Babikian Healthcare Products CJSCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 29, 2026fda.gov
September 18, 2026Curia New York, Inc.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedSeptember 29, 2026fda.gov
September 18, 2026Empower Clinic Services, LLC dba Empower PharmacyCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugSeptember 22, 2026fda.gov
September 17, 2026Bentley Laboratories LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedSeptember 29, 2026fda.gov
September 14, 2026SCA Pharmaceuticals, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 13, 2026fda.gov
September 14, 2026CelmadeCenter for Drug Evaluation and ResearchReview of Website/Unapproved New Drug/MisbrandedSeptember 29, 2026fda.gov
September 11, 2026RDM Express Inc.Human Foods ProgramCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedOctober 13, 2026fda.gov
September 11, 2026Ocean Pride Seafood, Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsOctober 13, 2026fda.gov
September 11, 2026NexCell Scientific IncCenter for Biologics Evaluation and ResearchUnapproved New Drugs/Unlicensed Biological Product ViolationsSeptember 22, 2026fda.gov
September 9, 2026Safi Pushcart Supplies Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)November 3, 2026fda.gov
September 9, 2026Moda Food LLCOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)October 13, 2026fda.gov
September 8, 2026kdc/one Chatsworth, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 22, 2026fda.gov
September 4, 2026Bausch & Lomb Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 15, 2026fda.gov
September 2, 2026TCI Co., Ltd BioCosme PABP BRANCHCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 6, 2026fda.gov
September 1, 2026Star Ocean Wholesale Foods, Inc.Office of Inspections and InvestigationsSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsOctober 6, 2026fda.gov
September 1, 2026O.N. Diagnostics, LLCCenter for Devices and Radiological HealthMedical Device Reporting/MisbrandedOctober 6, 2026fda.gov
September 1, 2026Happy Farm Botanicals, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 8, 2026fda.gov
August 28, 2026Tipical Latin Food, Corp. DBA La PraderaHuman Foods ProgramCGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary ConditionsOctober 6, 2026fda.gov
August 27, 2026Andrighetto Produce Inc dba Shasta Produce IncOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)September 29, 2026fda.gov
August 27, 2026Union Trade Inc.Office of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)September 22, 2026fda.gov
August 27, 2026Stephen J. Fallon, Ph.D.Center for Biologics Evaluation and ResearchBioresearch Monitoring Program/Institutional Review Board (IRB)September 8, 2026fda.gov
August 27, 2026Jabil Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 1, 2026fda.gov
August 26, 2026Peter Schiff EnterprisesCenter for Devices and Radiological HealthMedical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)October 27, 2026fda.gov
August 25, 2026Advance-Esthetic LLCCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated DeviceSeptember 22, 2026fda.gov
August 25, 2026Fresenius Medical Care AG & Co. KGaACenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 1, 2026fda.gov
August 24, 2026BioDrive, Inc.Human Foods ProgramDietary Supplement/AdulteratedSeptember 22, 2026fda.gov
August 24, 2026TXP Innovations LLC dba Tex PeptidesCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedSeptember 1, 2026fda.gov
August 24, 2026Royal Peptides LLCCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedSeptember 1, 2026fda.gov
August 24, 2026Peptide Partners LLCCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedSeptember 1, 2026fda.gov
August 24, 2026Peak Performance PeptidesCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedSeptember 1, 2026fda.gov
August 24, 2026NuScience Peptides LLCCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedSeptember 1, 2026fda.gov
August 21, 2026Raaw Energy LLCCenter for Veterinary MedicineAdulterated Animal Foods/MisbrandedSeptember 22, 2026fda.gov
August 21, 2026Lion Street Medical, d/b/a Pensar Medical LLCCenter for Devices and Radiological HealthMedical Device Reporting/MisbrandedSeptember 22, 2026fda.gov
August 20, 2026South Asian Food Inc.Human Foods ProgramSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsSeptember 29, 2026fda.gov
August 19, 2026Next Medical Products Company, LLCCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/AdulteratedNovember 3, 2026fda.gov
August 18, 2026Binh Minh TofuHuman Foods ProgramCGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/AdulteratedSeptember 22, 2026fda.gov
August 18, 2026Shoolin Pharma Chem LLPCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedSeptember 1, 2026fda.gov
August 18, 2026Reliance Life Sciences Private LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 1, 2026fda.gov
August 18, 2026PReye, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugSeptember 1, 2026fda.gov
August 18, 2026B&P Mutual CorpOffice of Inspections and InvestigationsForeign Supplier Verification Program (FSVP)September 1, 2026fda.gov

By subject group

Subject groupLettersLatest
Unapproved drugs, marketing and online sales354October 30, 2026
Tobacco products289October 27, 2026
Drug manufacturing (CGMP)235October 29, 2026
Food safety183October 16, 2026
Medical devices92October 7, 2026
Clinical research and labs36October 6, 2026
Animal drugs and feed36October 2, 2026
Biologics, cells and tissue29October 13, 2026
Dietary supplements25September 29, 2026
Drug compounding24August 7, 2026
Other subjects8October 27, 2026

By issuing office

Issuing officeLettersLatest
Center for Drug Evaluation and Research604October 30, 2026
Center for Tobacco Products290October 27, 2026
Human Foods Program117September 29, 2026
Center for Devices and Radiological Health101October 7, 2026
Office of Inspections and Investigations71October 16, 2026
Center for Veterinary Medicine44October 2, 2026
Center for Biologics Evaluation and Research39October 13, 2026
Division of Northeast Imports11January 16, 2026
Division of Southwest Imports8September 24, 2025
The Office of Prescription Drug Promotion4August 12, 2026
Office of Compliance and Biologics Quality4March 12, 2026
Division of West Coast Imports4October 9, 2025
Division of Northern Border Imports3January 15, 2026
Office of Manufacturing Quality3December 1, 2025
Division of Southeast Imports3October 24, 2025
Office of Compliance and Enforcement2November 28, 2025
Office of Surveillance and Compliance1April 30, 2026
Office of Unapproved Drugs and Labeling Compliance1May 30, 2025
ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality1January 21, 2025

By year issued

YearLettersLatest
2025737December 30, 2025
2026503October 30, 2026
202471December 30, 2024

Where FDA publishes its 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. Spot a wrong value? Write to [email protected] with the link to this page.