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Center for Drug Evaluation and Research (CDER)

946 FDA 510(k) clearances · Issuing office

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◉ Watch Center for Drug Evaluation and Research (CDER)

RecordFirmDate
Jabil Inc. - FDA Warning Letter (2026-08-27)2026-08-27
Fresenius Medical Care AG & Co. KGaA - FDA Warning Letter (2026-08-25)2026-08-25
TXP Innovations LLC dba Tex Peptides - FDA Warning Letter (2026-08-24)2026-08-24
Royal Peptides LLC - FDA Warning Letter (2026-08-24)2026-08-24
NuScience Peptides LLC - FDA Warning Letter (2026-08-24)2026-08-24
Peptide Partners LLC - FDA Warning Letter (2026-08-24)2026-08-24
Peak Performance Peptides - FDA Warning Letter (2026-08-24)2026-08-24
Reliance Life Sciences Private Limited - FDA Warning Letter (2026-08-18)2026-08-18
Shoolin Pharma Chem LLP - FDA Warning Letter (2026-08-18)2026-08-18
PReye, LLC - FDA Warning Letter (2026-08-18)2026-08-18
Suretec Innovations, LLC - FDA Warning Letter (2026-08-13)2026-08-13
Eugia Pharma Specialities Limited - FDA Warning Letter (2026-08-13)2026-08-13
K.C. Pharmaceuticals, Inc. - FDA Warning Letter (2026-08-12)2026-08-12
Auriga Research Pvt. Ltd. - FDA Warning Letter (2026-08-12)2026-08-12
Safrel Pharmaceuticals LLC - FDA Warning Letter (2026-08-07)2026-08-07
Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd. - FDA Warning Letter (2026-08-06)2026-08-06
Maria E. De La Torre Silva, M.D. - FDA Warning Letter (2026-07-27)2026-07-27
Woodbine Products Company Inc. - FDA Warning Letter (2026-07-27)2026-07-27
Dabur India Limited - FDA Warning Letter (2026-07-24)2026-07-24
Thomas Brunner Hygiene GmbH - FDA Warning Letter (2026-07-24)2026-07-24
Island Kinetics, Inc. d.b.a. CoValence Laboratories - FDA Warning Letter (2026-07-16)2026-07-16
Shimoga Chemicals - FDA Warning Letter (2026-07-13)2026-07-13
BioMylz Pvt. Ltd. - FDA Warning Letter (2026-07-13)2026-07-13
Almon Healthcare Private Limited - FDA Warning Letter (2026-07-13)2026-07-13
Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. - FDA Warning Letter (2026-07-10)2026-07-10
Spa De Soleil, Inc. - FDA Warning Letter (2026-07-08)2026-07-08
International Medication Systems Limited - FDA Warning Letter (2026-07-02)2026-07-02
Excelvision - Fareva - FDA Warning Letter (2026-06-25)2026-06-25
Wizcure Pharmaa Private Limited - FDA Warning Letter (2026-06-24)2026-06-24
LyfeUnit / www.lyfeunit.com - FDA Warning Letter (2026-06-23)2026-06-23
Buy Keta Online / www.buyketaonline.com - FDA Warning Letter (2026-06-23)2026-06-23
ketaminetroches.com - FDA Warning Letter (2026-06-23)2026-06-23
All Ketamine HCL / www.allketaminehcl.com - FDA Warning Letter (2026-06-23)2026-06-23
Med Shop Inc / www.medshopinc.com - FDA Warning Letter (2026-06-23)2026-06-23
Ketamine Troche Store / www.ketaminetrochestore.com - FDA Warning Letter (2026-06-23)2026-06-23
Ketamine Store / www.ketaminestore.org - FDA Warning Letter (2026-06-23)2026-06-23
Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com - FDA Warning Letter (2026-06-23)2026-06-23
Legit Ketamine Suppliers / www.legitketaminesuppliers.com - FDA Warning Letter (2026-06-23)2026-06-23
Ketacyn Pharmaceuticals / www.ketacynpharma.com - FDA Warning Letter (2026-06-23)2026-06-23
Keta Med Lab / www.ketamedlab.com - FDA Warning Letter (2026-06-23)2026-06-23
Extra Medication / www.extramedication.com - FDA Warning Letter (2026-06-23)2026-06-23
Ketdaxandrugs / www.ketdaxandrugs.org - FDA Warning Letter (2026-06-23)2026-06-23
Ket Plug / ketaminelab.org and buyketaminepowderonline.com - FDA Warning Letter (2026-06-23)2026-06-23
Amazon.com, Inc. - FDA Warning Letter (2026-06-17)2026-06-17
JJLBRO - FDA Warning Letter (2026-06-17)2026-06-17
Great India Overseas Pvt. Ltd. dba Silkrute - FDA Warning Letter (2026-06-17)2026-06-17
Telos Trading Limited dba Alwinshop - FDA Warning Letter (2026-06-17)2026-06-17
Indiangoods.shop - FDA Warning Letter (2026-06-17)2026-06-17
Wild Arabic Herbs - FDA Warning Letter (2026-06-17)2026-06-17
Hadassah Healing Oils Ltd - FDA Warning Letter (2026-06-17)2026-06-17
MantroForce - FDA Warning Letter (2026-06-17)2026-06-17
Wholesale Peptide - FDA Warning Letter (2026-06-17)2026-06-17
Leading Edge Health Inc. - FDA Warning Letter (2026-06-17)2026-06-17
Texinkart Inc. - FDA Warning Letter (2026-06-17)2026-06-17
Herbal Dermals LLC FZ dba Gotucream - FDA Warning Letter (2026-06-17)2026-06-17
Yangzhou Hongshengding Chemical Co., Ltd. - FDA Warning Letter (2026-06-15)2026-06-15
Huons Co., Ltd. - FDA Warning Letter (2026-06-15)2026-06-15
Maximus Health, Inc. dba Maximus - FDA Warning Letter (2026-06-08)2026-06-08
Trinity HealthCare Supply, LLC dba altRx - FDA Warning Letter (2026-06-08)2026-06-08
Glow Medispa, LLC dba Mint Med - FDA Warning Letter (2026-06-08)2026-06-08
Ezra Holdco LLC dba Ezra - FDA Warning Letter (2026-06-08)2026-06-08
Public Health Solution LLC dba DrMedHealth - FDA Warning Letter (2026-06-08)2026-06-08
D&H Medical Services - FDA Warning Letter (2026-06-08)2026-06-08
Amie Health, Inc. dba Amie - FDA Warning Letter (2026-06-08)2026-06-08
Altru Telehealth, LLC dba Altru Telehealth - FDA Warning Letter (2026-06-08)2026-06-08
Eden Health International Inc. dba Eden - FDA Warning Letter (2026-06-08)2026-06-08
NativeMed LLC dba NativeMed - FDA Warning Letter (2026-06-08)2026-06-08
FitRX, LLC dba AM RX - FDA Warning Letter (2026-06-08)2026-06-08
Momentum Health 360 dba Momentum Health - FDA Warning Letter (2026-06-08)2026-06-08
Medica Weight Loss - FDA Warning Letter (2026-06-08)2026-06-08
Clover Meds LLC dba Clover Meds - FDA Warning Letter (2026-06-08)2026-06-08
Nexlife Inc. dba Nexlife - FDA Warning Letter (2026-06-08)2026-06-08
Roen Health, Inc. dba RoenRx - FDA Warning Letter (2026-06-08)2026-06-08
Joi and Blokes dba Joi + Blokes - FDA Warning Letter (2026-06-08)2026-06-08
VivioMD Group LLC dba VivioMD - FDA Warning Letter (2026-06-08)2026-06-08
Thrivelab Co. dba Thrivelab - FDA Warning Letter (2026-06-08)2026-06-08
Nexus Health Solutions LLC dba Harper Meds - FDA Warning Letter (2026-06-08)2026-06-08
Nova Vascular LLC dba NOVARX - FDA Warning Letter (2026-06-08)2026-06-08
Ready Med - FDA Warning Letter (2026-06-08)2026-06-08
OrderlyMeds LLC dba OrderlyMeds - FDA Warning Letter (2026-06-08)2026-06-08
HydraMed IV LLC dba HydraMed - FDA Warning Letter (2026-06-08)2026-06-08
FITISH - FDA Warning Letter (2026-06-08)2026-06-08
Sante Manufacturing Inc. - FDA Warning Letter (2026-06-05)2026-06-05
InvaDerm, Inc. - FDA Warning Letter (2026-06-03)2026-06-03
Hubei Gedian Humanwell Pharmaceutical Co., Ltd. - FDA Warning Letter (2026-06-03)2026-06-03
Asanuma Corporation - Sagamihara Factory - FDA Warning Letter (2026-06-02)2026-06-02
Shantou Qiwei Industry Co., LTD - FDA Warning Letter (2026-06-02)2026-06-02
Revlon Group Holdings, LLC - FDA Warning Letter (2026-06-02)2026-06-02
Umendra Life Sciences Private Limited - FDA Warning Letter (2026-06-02)2026-06-02
Erkul Kozmetik Sanayi ve Ticaret A.S. - FDA Warning Letter (2026-06-02)2026-06-02
PLZ Corp - FDA Warning Letter (2026-06-02)2026-06-02
Zydus Lifesciences Limited - FDA Warning Letter (2026-06-02)2026-06-02
Laboratorios Dr. Collado S.A. - FDA Warning Letter (2026-06-02)2026-06-02
Gopaldas Visram & Co., Ltd. - FDA Warning Letter (2026-06-02)2026-06-02
Macau-Union Pharmaceutical Limited - FDA Warning Letter (2026-05-29)2026-05-29
Jubilant HollisterStier General Partnership - FDA Warning Letter (2026-05-28)2026-05-28
Jose M. Carpio, M.D. - FDA Warning Letter (2026-05-28)2026-05-28
Medline Inc - FDA Warning Letter (2026-05-28)2026-05-28
Pharmathen International S.A. - FDA Warning Letter (2026-05-27)2026-05-27
Laboratorios Jaloma S.A. de C.V. - FDA Warning Letter (2026-05-22)2026-05-22
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