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 1405-1416 of 1819 letters

ALApproval Letter
Approval Letter KENVUE BRANDS (Mar 27, 2026)
FDA posted an approval letter for CHILDREN'S ZYRTEC ALLERGY, CHILDREN'S ZYRTEC HIVES RELIEF on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021621 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 27, 2026
US FDA• CHILDREN'S ZYRTEC ALLERGY / CHILDREN'S ZYRTEC HIVES RELIEF
ALApproval Letter
Approval Letter OTSUKA ICU MEDCL (Mar 27, 2026)
FDA posted an approval letter for RINGER'S IN PLASTIC CONTAINER on 2026-03-27. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 018251 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 27, 2026
US FDA• RINGER'S IN PLASTIC CONTAINER
WLWarning Letter
Warning Letter Ehsan Sadri, M.D. (Mar 27, 2026)
FDA issued a warning letter to Ehsan Sadri, M.D. concerning Clinical Investigator. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Quality systems and CAPA, 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.
IssuedMar 27, 2026
US FDA• Clinical Investigator
WLWarning Letter
Warning Letter buydeltas.com (Mar 27, 2026)
FDA issued a warning letter to buydeltas.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Unapproved products and premarket authorization, Tobacco product authorization and marketing, 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.
IssuedMar 27, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Baja Fresko Distributors Inc. (Mar 27, 2026)
FDA issued a warning letter to Baja Fresko Distributors 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.
IssuedMar 27, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter J&B Food Consulting (Mar 27, 2026)
FDA issued a warning letter to J&B Food Consulting 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.
IssuedMar 27, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Eaglelionton Int'l Trading Co Inc (Mar 26, 2026)
FDA issued a warning letter to Eaglelionton Int'l Trading Co 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.
IssuedMar 26, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Henan Lvyuan Pharmaceutical Co. Ltd. (Mar 26, 2026)
FDA issued a warning letter to Henan Lvyuan Pharmaceutical Co. Ltd. concerning CGMP/API/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, 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.
IssuedMar 26, 2026
US FDA• CGMP/API/Adulterated
ALApproval Letter
Approval Letter MERZ PHARMS (Mar 25, 2026)
FDA posted an approval letter for Xeomin on 2026-03-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 125360 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 25, 2026
US FDA• Xeomin
ALApproval Letter
Approval Letter LONG GROVE PHARMS (Mar 25, 2026)
FDA posted an approval letter for AK-FLUOR 10%, AK-FLUOR 25% on 2026-03-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022186 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 25, 2026
US FDA• AK-FLUOR 10% / AK-FLUOR 25%
WLWarning Letter
Warning Letter Medline Industries, LP (Mar 25, 2026)
FDA issued a warning letter to Medline Industries, LP 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.
IssuedMar 25, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
ALApproval Letter
Approval Letter GLAXOSMITHKLINE (Mar 24, 2026)
FDA posted an approval letter for MALARONE, MALARONE PEDIATRIC on 2026-03-24. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 021078 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 24, 2026
US FDA• MALARONE / MALARONE PEDIATRIC

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Approval Letter KENVUE BRANDS (Mar 27, 2026)

Approval Letter OTSUKA ICU MEDCL (Mar 27, 2026)

Warning Letter Ehsan Sadri, M.D. (Mar 27, 2026)

Warning Letter buydeltas.com (Mar 27, 2026)

Warning Letter Baja Fresko Distributors Inc. (Mar 27, 2026)

Warning Letter J&B Food Consulting (Mar 27, 2026)

Warning Letter Eaglelionton Int'l Trading Co Inc (Mar 26, 2026)

Warning Letter Henan Lvyuan Pharmaceutical Co. Ltd. (Mar 26, 2026)

Approval Letter MERZ PHARMS (Mar 25, 2026)

Approval Letter LONG GROVE PHARMS (Mar 25, 2026)

Warning Letter Medline Industries, LP (Mar 25, 2026)

Approval Letter GLAXOSMITHKLINE (Mar 24, 2026)