FDA LETTER LIBRARY

FDA application & warning letters

Name: FDA Approval, Complete Response & Warning Letters
Creator: Assyro AI
License: https://www.usa.gov/government-works

Review 1,819 source-backed approval, tentative approval, complete response, and warning letters. Application letters cover 2026; the CRL corpus is complete as published by openFDA, and warning letters cover 2026.

Showing 1117-1128 of 1819 letters

ALApproval Letter
Approval Letter ACCORD HLTHCARE (May 26, 2026)
FDA posted an approval letter for ARGATROBAN IN SODIUM CHLORIDE on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 212035 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• ARGATROBAN IN SODIUM CHLORIDE
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (May 26, 2026)
FDA posted an approval letter for HEPCLUDEX on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761468 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• HEPCLUDEX
ALApproval Letter
Approval Letter APOTEX (May 26, 2026)
FDA posted an approval letter for MULTIPLE VITAMINS INJECTION ADULT on 2026-05-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 210672 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 26, 2026
US FDA• MULTIPLE VITAMINS INJECTION ADULT
WLWarning Letter
Warning Letter AF Import & Wholesale Co (May 26, 2026)
FDA issued a warning letter to AF Import & Wholesale Co concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 26, 2026
US FDA• Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
WLWarning Letter
Warning Letter Blue Horizon International, LLC (May 26, 2026)
FDA issued a warning letter to Blue Horizon International, LLC concerning Unapproved New Drugs/Unlicensed Biological Product Violations. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Unapproved products and premarket authorization. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 26, 2026
US FDA• Unapproved New Drugs/Unlicensed Biological Product Violations
WLWarning Letter
Warning Letter Pamex Foods Incorporated (May 26, 2026)
FDA issued a warning letter to Pamex Foods Incorporated concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 26, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
ALApproval Letter
Approval Letter GALDERMA LABS LP (May 22, 2026)
FDA posted an approval letter for DIFFERIN EPIDUO, DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) on 2026-05-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220736 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 22, 2026
US FDA• DIFFERIN EPIDUO / DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)
WLWarning Letter
Warning Letter ZIIP, Inc. (May 22, 2026)
FDA issued a warning letter to ZIIP, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Labeling, claims, and misbranding, Medical device quality and reporting, Manufacturing and CGMP controls. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 22, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
WLWarning Letter
Warning Letter Laboratorios Jaloma S.A. de C.V. (May 22, 2026)
FDA issued a warning letter to Laboratorios Jaloma S.A. de C.V. concerning CGMP/OTC/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Quality systems and CAPA, Labeling, claims, and misbranding. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 22, 2026
US FDA• CGMP/OTC/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Aeroflex Industria de Aerosol Ltda. (May 22, 2026)
FDA issued a warning letter to Aeroflex Industria de Aerosol Ltda. concerning Refusal to Provide Access to and Copying of Records. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
IssuedMay 22, 2026
US FDA• Refusal to Provide Access to and Copying of Records
ALApproval Letter
Approval Letter ABBVIE (May 21, 2026)
FDA posted an approval letter for RINVOQ LQ on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218347 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 21, 2026
US FDA• RINVOQ LQ
ALApproval Letter
Approval Letter BAYER HEALTHCARE LLC (May 21, 2026)
FDA posted an approval letter for CHILDREN'S CLARITIN, CLARITIN on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021891 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 21, 2026
US FDA• CHILDREN'S CLARITIN / CLARITIN

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Approval Letter ACCORD HLTHCARE (May 26, 2026)

Approval Letter GILEAD SCIENCES INC (May 26, 2026)

Approval Letter APOTEX (May 26, 2026)

Warning Letter AF Import & Wholesale Co (May 26, 2026)

Warning Letter Blue Horizon International, LLC (May 26, 2026)

Warning Letter Pamex Foods Incorporated (May 26, 2026)

Approval Letter GALDERMA LABS LP (May 22, 2026)

Warning Letter ZIIP, Inc. (May 22, 2026)

Warning Letter Laboratorios Jaloma S.A. de C.V. (May 22, 2026)

Warning Letter Aeroflex Industria de Aerosol Ltda. (May 22, 2026)

Approval Letter ABBVIE (May 21, 2026)

Approval Letter BAYER HEALTHCARE LLC (May 21, 2026)