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 1,503 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 1417-1428 of 1503 letters

ALApproval Letter
Approval Letter GLAUKOS (Jan 28, 2026)
FDA issued an approval letter for IDOSE TR on 2026-01-28. The source metadata identifies NDA 218010 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 28, 2026
US FDA• IDOSE TR
WLWarning Letter
Warning Letter Beta Bionics, Inc. (Jan 28, 2026)
FDA issued a warning letter to Beta Bionics, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, 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.
IssuedJan 28, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
WLWarning Letter
Warning Letter Beta Bionics, Inc. (Jan 28, 2026)
FDA issued a warning letter to Beta Bionics, Inc. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, 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.
IssuedJan 28, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
ALApproval Letter
Approval Letter SCHERING (Jan 27, 2026)
FDA issued an approval letter for NOXAFIL, NOXAFIL POWDERMIX KIT on 2026-01-27. The source metadata identifies NDA 022003, NDA 205053, NDA 205596, NDA 214770 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 27, 2026
US FDA• NOXAFIL / NOXAFIL POWDERMIX KIT
ALApproval Letter
Approval Letter SOLUBIOMIX (Jan 27, 2026)
FDA issued an approval letter for QUIOFIC on 2026-01-27. The source metadata identifies NDA 216395 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 27, 2026
US FDA• QUIOFIC
ALApproval Letter
Approval Letter AVION PHARMS (Jan 27, 2026)
FDA issued an approval letter for PONSTEL on 2026-01-27. The source metadata identifies NDA 015034 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 27, 2026
US FDA• PONSTEL
WLWarning Letter
Warning Letter Flextronics America LLC (Jan 27, 2026)
FDA issued a warning letter to Flextronics America LLC concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Manufacturing and CGMP controls, Medical device quality and reporting, 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.
IssuedJan 27, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
WLWarning Letter
Warning Letter Conceive Fertility Center (Jan 27, 2026)
FDA issued a warning letter to Conceive Fertility Center concerning Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps). Deterministic full-text screening identifies discussion of Laboratory controls and testing, 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.
IssuedJan 27, 2026
US FDA• Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
WLWarning Letter
Warning Letter HTO Nevada, Inc. dba Kirkman (Jan 27, 2026)
FDA issued a warning letter to HTO Nevada, Inc. dba Kirkman concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic source-metadata screening identifies discussion of 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.
IssuedJan 27, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter MANNKIND (Jan 26, 2026)
FDA issued an approval letter for AFREZZA on 2026-01-26. The source metadata identifies BLA 022472 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 26, 2026
US FDA• AFREZZA
ALApproval Letter
Approval Letter SAMSUNG BIOEPIS CO LTD (Jan 26, 2026)
FDA issued an approval letter for EPYSQLI on 2026-01-26. The source metadata identifies BLA 761340 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 26, 2026
US FDA• EPYSQLI
ALApproval Letter
Approval Letter VERTEX PHARMS INC (Jan 26, 2026)
FDA issued an approval letter for JOURNAVX on 2026-01-26. The source metadata identifies NDA 219209 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJan 26, 2026
US FDA• JOURNAVX

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Approval Letter GLAUKOS (Jan 28, 2026)

Warning Letter Beta Bionics, Inc. (Jan 28, 2026)

Warning Letter Beta Bionics, Inc. (Jan 28, 2026)

Approval Letter SCHERING (Jan 27, 2026)

Approval Letter SOLUBIOMIX (Jan 27, 2026)

Approval Letter AVION PHARMS (Jan 27, 2026)

Warning Letter Flextronics America LLC (Jan 27, 2026)

Warning Letter Conceive Fertility Center (Jan 27, 2026)

Warning Letter HTO Nevada, Inc. dba Kirkman (Jan 27, 2026)

Approval Letter MANNKIND (Jan 26, 2026)

Approval Letter SAMSUNG BIOEPIS CO LTD (Jan 26, 2026)

Approval Letter VERTEX PHARMS INC (Jan 26, 2026)