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[ FDA WARNING LETTERS ]
What the FDA is calling out, in writing.
Warning Letters are the FDA’s formal notice that a firm is significantly out of compliance — inspection-readiness gold. SPEQ tracks the recipient, issuing office, and subject of each recent letter, with a link to the full text.
53
Letters tracked
Jul 28, 2026
Most recent
7
Issuing offices
Center for Drug Evaluation and Research (CDER) · 18Office of Inspections and Investigations · 13The Office of Prescription Drug Promotion (OPDP) · 7Center for Tobacco Products · 5Human Foods Program · 4
Jul 28, 2026Human Foods Program
San Jorge Produce LLC
Foreign Supplier Verification Program (FSVP)
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Jul 28, 2026Human Foods Program
VasoCorp, Inc.
Unapproved New Drugs/Misbranded
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Jul 28, 2026Office of Inspections and Investigations
Piquin Y Sabores Distributors LLC
Foreign Supplier Verification Program (FSVP)
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Jul 28, 2026Office of Inspections and Investigations
Delight Distribution Inc.
Foreign Supplier Verification Program (FSVP)
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Jul 28, 2026Office of Inspections and Investigations
Eherbs Imports, Inc
Foreign Supplier Verification Program (FSVP)
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Jul 28, 2026Center for Veterinary Medicine
AHC Products, Inc.
CGMP/Finished Pharmaceuticals/Adulterated
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Jul 28, 2026Office of Inspections and Investigations
Prida Import & Export LLC
Foreign Supplier Verification Program (FSVP)
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Jul 22, 2026Center for Devices and Radiological Health
Linemaster Switch Corporation
CGMP/QSR/Drug/Medical Devices/Adulterated
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Jul 21, 2026Office of Inspections and Investigations
Beauty Store LLC
Foreign Supplier Verification Program (FSVP)
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Jul 21, 2026Center for Drug Evaluation and Research (CDER)
Almon Healthcare Private Limited
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
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Jul 21, 2026Office of Inspections and Investigations
Shang Hao Jia, Inc.
Foreign Supplier Verification Program (FSVP)
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Jul 21, 2026Center for Tobacco Products
mkpodplug.co.uk
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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Jul 21, 2026Center for Drug Evaluation and Research (CDER)
Alembic Pharmaceuticals Ltd.
In Vivo Bioavailability-Bioequivalence Studies – Clinical
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Jul 21, 2026Center for Tobacco Products
indejuicevapestore.co.uk
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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Jul 21, 2026Office of Inspections and Investigations
IJAJ Group Inc DBA Sanz Wholesale Foods
Foreign Supplier Verification Program (FSVP)
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Jul 21, 2026Center for Tobacco Products
ejuicedemand.com
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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Jul 21, 2026Center for Drug Evaluation and Research (CDER)
Shimoga Chemicals
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
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Jul 21, 2026Center for Drug Evaluation and Research (CDER)
Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.
In Vivo Bioavailability-Bioequivalence Studies – Clinical
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Jul 21, 2026Human Foods Program
Mineral BioSciences, LLC
Unapproved New Drugs/Misbranded
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Jul 21, 2026Center for Veterinary Medicine
Fareva Amboise
CGMP/Finished Pharmaceuticals/Adulterated
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Jul 21, 2026Center for Drug Evaluation and Research (CDER)
Island Kinetics, Inc. d.b.a. CoValence Laboratories
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
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Jul 21, 2026Center for Drug Evaluation and Research (CDER)
BioMylz Pvt. Ltd.
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
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Jul 21, 2026Office of Inspections and Investigations
Balkanica LLC
Foreign Supplier Verification Program (FSVP)
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Jul 14, 2026Center for Drug Evaluation and Research (CDER)
International Medication Systems Limited
CGMP/Finished Pharmaceuticals/Adulterated
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Jul 14, 2026Office of Inspections and Investigations
J&B Food Consulting
Foreign Supplier Verification Program (FSVP)
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Jul 14, 2026Office of Inspections and Investigations
Diamond Distributions LLC
Foreign Supplier Verification Program (FSVP)
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Jul 14, 2026Office of Inspections and Investigations
AF Import & Wholesale Co
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
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Jul 14, 2026Center for Devices and Radiological Health
ZIIP, Inc.
CGMP/QSR/Medical Devices/Adulterated
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Jul 14, 2026Center for Drug Evaluation and Research (CDER)
Spa De Soleil, Inc.
CGMP/Finished Pharmaceuticals/Adulterated
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Jul 14, 2026Center for Devices and Radiological Health
Nihon Kohden Digital Health Solutions, LLC
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
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Jul 14, 2026Center for Tobacco Products
eliquidflavourconcentrates.co.uk
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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Jul 14, 2026Office of Inspections and Investigations
Full Fresh Produce LLC
Foreign Supplier Verification Program (FSVP)
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Jul 14, 2026Center for Veterinary Medicine
Allandale Dairy
New Animal Drug/Adulterated
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Jul 14, 2026Human Foods Program
Nutratech, LLC
CGMP/Dietary Supplement/Adulterated/Misbranded
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Jul 14, 2026Center for Tobacco Products
snusblast.co.uk
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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Jul 14, 2026Office of Inspections and Investigations
Win Woo Trading, LLC / HF Foods Group
Foreign Supplier Verification Program (FSVP)
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
Ketamine Store / www.ketaminestore.org
Unapproved New Drugs/Misbranded
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
Extra Medication / www.extramedication.com
Unapproved New Drugs/Misbranded
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com
Unapproved New Drugs/Misbranded
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
All Ketamine HCL / www.allketaminehcl.com
Unapproved New Drugs/Misbranded
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
Ketamine Troche Store / www.ketaminetrochestore.com
Unapproved New Drugs/Misbranded
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
Buy Keta Online / www.buyketaonline.com
Unapproved New Drugs/Misbranded
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
Ketacyn Pharmaceuticals / www.ketacynpharma.com
Unapproved New Drugs/Misbranded
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
Legit Ketamine Suppliers / www.legitketaminesuppliers.com
Unapproved New Drugs/Misbranded
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
Ketdaxandrugs / www.ketdaxandrugs.org
Unapproved New Drugs/Misbranded
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Jul 7, 2026Center for Drug Evaluation and Research (CDER)
ketaminetroches.com
Unapproved New Drugs/Misbranded
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Mar 24, 2026The Office of Prescription Drug Promotion (OPDP)
ImmunityBio, Inc.
False & Misleading Claims/Misbranded
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Jun 10, 2025The Office of Prescription Drug Promotion (OPDP)
Sprout Pharmaceuticals, Inc.
False & Misleading Claims/Misbranded
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May 20, 2025The Office of Prescription Drug Promotion (OPDP)
Sarfez Pharmaceuticals, Inc.
False & Misleading Claims/Misbranded
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Aug 15, 2023The Office of Prescription Drug Promotion (OPDP)
AstraZeneca Pharmaceuticals LP
False & Misleading Claims/Misbranded
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Feb 22, 2022The Office of Prescription Drug Promotion (OPDP)
CytoDyn, Inc.
New Drug/Labeling/Misbranded
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Feb 23, 2021The Office of Prescription Drug Promotion (OPDP)
CooperSurgical, Inc.
False & Misleading Claims/Misbranded
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Feb 16, 2021The Office of Prescription Drug Promotion (OPDP)
AcelRx Pharmaceuticals, Inc.
False & Misleading Claims/Misbranded
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Source: U.S. FDA Warning Letters (fda.gov), scraped and refreshed weekly. Warning letters are FDA records reproduced as published — SPEQ adds no interpretation. The archive builds forward from the first scan.