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 1129-1140 of 1819 letters

ALApproval Letter
Approval Letter FRESENIUS KABI USA (May 21, 2026)
FDA posted an approval letter for TYENNE on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761449 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 21, 2026
US FDA• TYENNE
ALApproval Letter
Approval Letter CHATTEM SANOFI (May 21, 2026)
FDA posted an approval letter for XYZAL ALLERGY 24HR on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209089 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 21, 2026
US FDA• XYZAL ALLERGY 24HR
ALApproval Letter
Approval Letter FRESENIUS KABI USA (May 21, 2026)
FDA posted an approval letter for TYENNE on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761275 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 21, 2026
US FDA• TYENNE
ALApproval Letter
Approval Letter MIRUM (May 21, 2026)
FDA posted an approval letter for CHOLBAM on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205750 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 21, 2026
US FDA• CHOLBAM
ALApproval Letter
Approval Letter ORGANON (May 21, 2026)
FDA posted an approval letter for REMERON on 2026-05-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 020415 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 21, 2026
US FDA• REMERON
WLWarning Letter
Warning Letter Alchymars ICM SM Private Limited (May 21, 2026)
FDA issued a warning letter to Alchymars ICM SM Private Limited concerning CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Quality systems and CAPA, Laboratory controls and testing, Data integrity and records. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 21, 2026
US FDA• CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
WLWarning Letter
Warning Letter BMC Medical Co., Ltd. (May 20, 2026)
FDA issued a warning letter to BMC Medical Co., Ltd. concerning CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Unapproved products and premarket authorization, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 20, 2026
US FDA• CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
WLWarning Letter
Warning Letter Aversa's Italian Bakery (May 20, 2026)
FDA issued a warning letter to Aversa's Italian Bakery concerning CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Food safety and supplier verification, 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 20, 2026
US FDA• CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
WLWarning Letter
Warning Letter Golden Dakota Farms LLC (May 20, 2026)
FDA issued a warning letter to Golden Dakota Farms LLC concerning New Animal Drug/Adulterated. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Quality systems and CAPA. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMay 20, 2026
US FDA• New Animal Drug/Adulterated
WLWarning Letter
Warning Letter 3B Medical, Inc. dba Reach Health, Inc. (May 20, 2026)
FDA issued a warning letter to 3B Medical, Inc. dba Reach Health, 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.
IssuedMay 20, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
ALApproval Letter
Approval Letter INCYTE CORP (May 19, 2026)
FDA posted an approval letter for ZYNYZ on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761334 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 19, 2026
US FDA• ZYNYZ
ALApproval Letter
Approval Letter GENENTECH INC (May 19, 2026)
FDA posted an approval letter for PHESGO on 2026-05-19. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761170 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 19, 2026
US FDA• PHESGO

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Approval Letter FRESENIUS KABI USA (May 21, 2026)

Approval Letter CHATTEM SANOFI (May 21, 2026)

Approval Letter FRESENIUS KABI USA (May 21, 2026)

Approval Letter MIRUM (May 21, 2026)

Approval Letter ORGANON (May 21, 2026)

Warning Letter Alchymars ICM SM Private Limited (May 21, 2026)

Warning Letter BMC Medical Co., Ltd. (May 20, 2026)

Warning Letter Aversa's Italian Bakery (May 20, 2026)

Warning Letter Golden Dakota Farms LLC (May 20, 2026)

Warning Letter 3B Medical, Inc. dba Reach Health, Inc. (May 20, 2026)

Approval Letter INCYTE CORP (May 19, 2026)

Approval Letter GENENTECH INC (May 19, 2026)