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Data / FDA warning letters / Center for Drug Evaluation and Research

Center for Drug Evaluation and Research: 604 warning letters

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. The list gains about 15 rows a month. The new rows come each week by email, $19 a month.

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

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 request: Every new FDA warning letter from the Center for Drug Evaluation and Research, with the company, the subject and the letter.

SpecStream is the live web data engine for teams and agents. It reads FDA's warning letters table each morning, and this page is that reading. Ask for the offices, subjects or companies you follow and each new letter arrives in your sheet, CRM, Slack or agent as FDA posts it.

  • 604Letters
  • 9With closeout
  • October 30, 2026Latest issued

Newest letters

The newest 100 of 604 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, 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 14, 2026Rohto Pharmaceutical Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedOctober 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, 2026Silgan Dispensing SystemsCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/Unapproved New DrugOctober 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, 2026Baxter International Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 2026fda.gov
September 28, 2026SnugZ USA, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedOctober 20, 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 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 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, 2026Happy Farm Botanicals, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 8, 2026fda.gov
August 27, 2026Jabil Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 1, 2026fda.gov
August 25, 2026Fresenius Medical Care AG & Co. KGaACenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedSeptember 1, 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 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 13, 2026Suretec Innovations, LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated and MisbrandedAugust 18, 2026fda.gov
August 13, 2026Eugia Pharma Specialities LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 18, 2026fda.gov
August 12, 2026K.C. Pharmaceuticals, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 18, 2026fda.gov
August 12, 2026Auriga Research Pvt. Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 18, 2026fda.gov
August 7, 2026Pine Pharmaceuticals, LLCCenter for Drug Evaluation and ResearchCompounding Pharmacy/Adulterated Drug ProductsOctober 6, 2026fda.gov
August 7, 2026Safrel Pharmaceuticals LLCCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 18, 2026fda.gov
August 6, 2026Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/Adulterated/MisbrandedAugust 18, 2026fda.gov
July 31, 2026FairyGene, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedAugust 11, 2026fda.gov
July 30, 2026Lico Industries, LLC., d.b.a. American Towelette CompanyCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 11, 2026fda.gov
July 27, 2026Woodbine Products Company Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 4, 2026fda.gov
July 27, 2026Maria E. De La Torre Silva, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorAugust 4, 2026fda.gov
July 24, 2026Thomas Brunner Hygiene GmbHCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedAugust 4, 2026fda.gov
July 24, 2026Dabur India LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedAugust 4, 2026fda.gov
July 16, 2026Island Kinetics, Inc. d.b.a. CoValence LaboratoriesCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/AdulteratedJuly 21, 2026fda.gov
July 13, 2026Shimoga ChemicalsCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedJuly 21, 2026fda.gov
July 13, 2026BioMylz Pvt. Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/Adulterated/MisbrandedJuly 21, 2026fda.gov
July 13, 2026Almon Healthcare Private LimitedCenter for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedJuly 21, 2026fda.gov
July 10, 2026Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.Center for Drug Evaluation and ResearchIn Vivo Bioavailability-Bioequivalence Studies – ClinicalJuly 21, 2026fda.gov
July 8, 2026Spa De Soleil, Inc.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJuly 14, 2026fda.gov
July 2, 2026International Medication Systems LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJuly 14, 2026fda.gov
June 25, 2026Excelvision - FarevaCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJune 30, 2026fda.gov
June 24, 2026Wizcure Pharmaa Private LimitedCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedJune 30, 2026fda.gov
June 23, 2026Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Med Shop Inc / www.medshopinc.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026LyfeUnit / www.lyfeunit.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Legit Ketamine Suppliers / www.legitketaminesuppliers.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Ketdaxandrugs / www.ketdaxandrugs.orgCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026ketaminetroches.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Ketamine Troche Store / www.ketaminetrochestore.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Ketamine Store / www.ketaminestore.orgCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Ketacyn Pharmaceuticals / www.ketacynpharma.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Keta Med Lab / www.ketamedlab.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Ket Plug / ketaminelab.org and buyketaminepowderonline.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Extra Medication / www.extramedication.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026Buy Keta Online / www.buyketaonline.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 23, 2026All Ketamine HCL / www.allketaminehcl.comCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJuly 7, 2026fda.gov
June 17, 2026Wild Arabic HerbsCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJune 23, 2026fda.gov
June 17, 2026Wholesale PeptideCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJune 23, 2026fda.gov
June 17, 2026Texinkart Inc.Center for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJune 23, 2026fda.gov
June 17, 2026Telos Trading Limited dba AlwinshopCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJune 23, 2026fda.gov
June 17, 2026MantroForceCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedJune 23, 2026fda.gov

By subject group

Subject groupLettersLatest
Unapproved drugs, marketing and online sales320October 30, 2026
Drug manufacturing (CGMP)225October 29, 2026
Clinical research and labs30October 6, 2026
Drug compounding24August 7, 2026
Other subjects4October 27, 2026
Food safety1June 25, 2025

By year issued

YearLettersLatest
2025314December 30, 2025
2026266October 30, 2026
202424December 19, 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.

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