warning letter database

FDA Warning Letters

An FDA Warning Letter is a formal notice the FDA sends a company after finding significant regulatory violations, typically following an inspection. Argus HQ tracks 223 published FDA Warning Letters from 2026 to 2026, each with an AI-generated summary and the specific violations cited, sourced from and linked back to fda.gov.

• BioMylz Pvt. Ltd. — CGMP/Finished Pharmaceuticals/Adulterated/Misbranded (2026-07-13)

  BioMylz Pvt. Ltd.·Center for Drug Evaluation and Research (CDER)·July 13, 2026·Other

• Shimoga Chemicals — CGMP/Active Pharmaceutical Ingredient (API)/Adulterated (2026-07-13)

  Shimoga Chemicals·Center for Drug Evaluation and Research (CDER)·July 13, 2026·Other

• ejuicedemand.com — Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded (2026-07-10)

  ejuicedemand.com·Center for Tobacco Products·July 10, 2026·Other

• Alembic Pharmaceuticals Ltd. — In Vivo Bioavailability-Bioequivalence Studies – Clinical (2026-07-10)

  Alembic Pharmaceuticals Ltd.·Center for Drug Evaluation and Research (CDER)·July 10, 2026·Other

• Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. — In Vivo Bioavailability-Bioequivalence Studies – Clinical (2026-07-10)

  Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.·Center for Drug Evaluation and Research (CDER)·July 10, 2026·Other

• indejuicevapestore.co.uk — Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded (2026-07-10)

  indejuicevapestore.co.uk·Center for Tobacco Products·July 10, 2026·Other

• VasoCorp, Inc. — Unapproved New Drugs/Misbranded (2026-07-09)

  VasoCorp, Inc.·Human Foods Program·July 9, 2026·Other

• IJAJ Group Inc DBA Sanz Wholesale Foods — Foreign Supplier Verification Program (FSVP) (2026-07-08)

  IJAJ Group Inc DBA Sanz Wholesale Foods·Office of Inspections and Investigations·July 8, 2026·Other

• Beauty Store LLC — Foreign Supplier Verification Program (FSVP) (2026-07-08)

  Beauty Store LLC·Office of Inspections and Investigations·July 8, 2026·Other

• Spa De Soleil, Inc. — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-08)

  Spa De Soleil, Inc.·Center for Drug Evaluation and Research (CDER)·July 8, 2026·Other

• Waves and Wine, Inc. — CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated (2026-07-06)

  Waves and Wine, Inc.·Center for Veterinary Medicine·July 6, 2026·Other

• Piquin Y Sabores Distributors LLC — Foreign Supplier Verification Program (FSVP) (2026-07-02)

  Piquin Y Sabores Distributors LLC·Office of Inspections and Investigations·July 2, 2026·Other

• snusblast.co.uk — Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded (2026-07-02)

  snusblast.co.uk·Center for Tobacco Products·July 2, 2026·Other

• International Medication Systems Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-07-02)

  International Medication Systems Limited·Center for Drug Evaluation and Research (CDER)·July 2, 2026·Other

• eliquidflavourconcentrates.co.uk — Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded (2026-07-02)

  eliquidflavourconcentrates.co.uk·Center for Tobacco Products·July 2, 2026·Other

• Balkanica LLC — Foreign Supplier Verification Program (FSVP) (2026-06-29)

  Balkanica LLC·Office of Inspections and Investigations·June 29, 2026·Other

• Excelvision - Fareva — CGMP/Finished Pharmaceuticals/Adulterated (2026-06-25)

  Excelvision - Fareva·Center for Drug Evaluation and Research (CDER)·June 25, 2026·Other

• Win Woo Trading, LLC / HF Foods Group — Foreign Supplier Verification Program (FSVP) (2026-06-24)

  Win Woo Trading, LLC / HF Foods Group·Office of Inspections and Investigations·June 24, 2026·Other

• Wizcure Pharmaa Private Limited — CGMP/Finished Pharmaceuticals/Adulterated (2026-06-24)

  Wizcure Pharmaa Private Limited·Center for Drug Evaluation and Research (CDER)·June 24, 2026·Other

• LyfeUnit / www.lyfeunit.com — Unapproved New Drugs/Misbranded (2026-06-23)

  LyfeUnit / www.lyfeunit.com·Center for Drug Evaluation and Research (CDER)·June 23, 2026·Other

• Allandale Dairy — New Animal Drug/Adulterated (2026-06-23)

  Allandale Dairy·Center for Veterinary Medicine·June 23, 2026·Other

• Extra Medication / www.extramedication.com — Unapproved New Drugs/Misbranded (2026-06-23)

  Extra Medication / www.extramedication.com·Center for Drug Evaluation and Research (CDER)·June 23, 2026·Other

• Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com — Unapproved New Drugs/Misbranded (2026-06-23)

  Pure Arylcyclohexylamine Store / www.arylcyclohexylamine.com·Center for Drug Evaluation and Research (CDER)·June 23, 2026·Other

• Buy Keta Online / www.buyketaonline.com — Unapproved New Drugs/Misbranded (2026-06-23)

  Buy Keta Online / www.buyketaonline.com·Center for Drug Evaluation and Research (CDER)·June 23, 2026·Other

• Ketdaxandrugs / www.ketdaxandrugs.org — Unapproved New Drugs/Misbranded (2026-06-23)

  Ketdaxandrugs / www.ketdaxandrugs.org·Center for Drug Evaluation and Research (CDER)·June 23, 2026·Other