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 529-540 of 1819 letters

ALApproval Letter
Approval Letter VIIV HLTHCARE (Aug 27, 2026)
FDA posted an approval letter for TIVICAY, TIVICAY PD on 2026-08-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 204790, NDA 213983 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 27, 2026
US FDA• TIVICAY / TIVICAY PD
WLWarning Letter
Warning Letter Stephen J. Fallon, Ph.D. (Aug 27, 2026)
FDA issued a warning letter to Stephen J. Fallon, Ph.D. concerning Bioresearch Monitoring Program/Institutional Review Board (IRB). Deterministic full-text screening identifies discussion of Clinical research and human-subject protections. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 27, 2026
US FDA• Bioresearch Monitoring Program/Institutional Review Board (IRB)
WLWarning Letter
Warning Letter Union Trade Inc. (Aug 27, 2026)
FDA issued a warning letter to Union Trade Inc. concerning Foreign Supplier Verification Program (FSVP). Deterministic full-text screening identifies discussion of Food safety and supplier verification, 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.
IssuedAug 27, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Jabil Inc. (Aug 27, 2026)
FDA issued a warning letter to Jabil Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 27, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Andrighetto Produce Inc dba Shasta Produce Inc (Aug 27, 2026)
FDA issued a warning letter to Andrighetto Produce Inc dba Shasta Produce Inc 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.
IssuedAug 27, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
ALApproval Letter
Approval Letter INFORLIFE (Aug 26, 2026)
FDA posted an approval letter for NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE on 2026-08-26. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215700 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 26, 2026
US FDA• NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
TATentative Approval Letter
Tentative Approval Letter SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD (Aug 25, 2026)
FDA posted a tentative approval letter for NDA 218328 on 2026-08-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218328 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 25, 2026
US FDA• NDA 218328
ALApproval Letter
Approval Letter GLAXOSMITHKLINE LLC (Aug 25, 2026)
FDA posted an approval letter for BENLYSTA on 2026-08-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761043, BLA 125370 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 25, 2026
US FDA• BENLYSTA
WLWarning Letter
Warning Letter Fresenius Medical Care AG & Co. KGaA (Aug 25, 2026)
FDA issued a warning letter to Fresenius Medical Care AG & Co. KGaA concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Labeling, claims, and misbranding, Laboratory controls and testing. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedAug 25, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Advance-Esthetic LLC (Aug 25, 2026)
FDA issued a warning letter to Advance-Esthetic LLC concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, 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.
IssuedAug 25, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
ALApproval Letter
Approval Letter VANTIVE US HLTHCARE (Aug 24, 2026)
FDA posted an approval letter for DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER on 2026-08-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017512 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 24, 2026
US FDA• DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER / DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER / DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
ALApproval Letter
Approval Letter NOVARTIS (Aug 24, 2026)
FDA posted an approval letter for SCEMBLIX on 2026-08-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215358 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAAug 24, 2026
US FDA• SCEMBLIX

Page 45 of 152

1…43 44 45 46 47…152

Approval Letter VIIV HLTHCARE (Aug 27, 2026)

Warning Letter Stephen J. Fallon, Ph.D. (Aug 27, 2026)

Warning Letter Union Trade Inc. (Aug 27, 2026)

Warning Letter Jabil Inc. (Aug 27, 2026)

Warning Letter Andrighetto Produce Inc dba Shasta Produce Inc (Aug 27, 2026)

Approval Letter INFORLIFE (Aug 26, 2026)

Tentative Approval Letter SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD (Aug 25, 2026)

Approval Letter GLAXOSMITHKLINE LLC (Aug 25, 2026)

Warning Letter Fresenius Medical Care AG & Co. KGaA (Aug 25, 2026)

Warning Letter Advance-Esthetic LLC (Aug 25, 2026)

Approval Letter VANTIVE US HLTHCARE (Aug 24, 2026)

Approval Letter NOVARTIS (Aug 24, 2026)