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 1681-1692 of 1819 letters

ALApproval Letter
Approval Letter ANI PHARMS (Feb 10, 2026)
FDA posted an approval letter for REGLAN on 2026-02-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 017854 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 10, 2026
US FDA• REGLAN
ALApproval Letter
Approval Letter QOL MEDCL (Feb 10, 2026)
FDA posted an approval letter for GIMOTI on 2026-02-10. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209388 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 10, 2026
US FDA• GIMOTI
WLWarning Letter
Warning Letter ProDx Health (Feb 10, 2026)
FDA issued a warning letter to ProDx Health concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). 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.
IssuedFeb 10, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WLWarning Letter
Warning Letter Hearthy Foods, Inc. (Feb 10, 2026)
FDA issued a warning letter to Hearthy Foods, Inc. concerning CGMP/Dietary Supplement/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, 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.
IssuedFeb 10, 2026
US FDA• CGMP/Dietary Supplement/Adulterated/Misbranded
WLWarning Letter
Warning Letter A TO Z Distributor Inc (Feb 10, 2026)
FDA issued a warning letter to A TO Z Distributor 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.
IssuedFeb 10, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
ALApproval Letter
Approval Letter BAXTER HLTHCARE CORP (Feb 9, 2026)
FDA posted an approval letter for NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE, NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE on 2026-02-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 214313 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 9, 2026
US FDA• NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE / NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
WLWarning Letter
Warning Letter VeganicSKN Limited (Feb 9, 2026)
FDA issued a warning letter to VeganicSKN Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, 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.
IssuedFeb 9, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Thrive Health and Wellness, LLC dba Thrive Health Solutions (Feb 9, 2026)
FDA issued a warning letter to Thrive Health and Wellness, LLC dba Thrive Health Solutions concerning Compounding Pharmacy/Adulterated Drug Products. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, 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.
IssuedFeb 9, 2026
US FDA• Compounding Pharmacy/Adulterated Drug Products
ALApproval Letter
Approval Letter CYTOKINETICS (Feb 6, 2026)
FDA posted an approval letter for MYQORZO on 2026-02-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219083 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 6, 2026
US FDA• MYQORZO
ALApproval Letter
Approval Letter PFIZER (Feb 6, 2026)
FDA posted an approval letter for IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE on 2026-02-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050734 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAFeb 6, 2026
US FDA• IDAMYCIN PFS / IDARUBICIN HYDROCHLORIDE
WLWarning Letter
Warning Letter Cosmetic Manufacturers Pty Ltd. (Feb 6, 2026)
FDA issued a warning letter to Cosmetic Manufacturers Pty Ltd. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Labeling, claims, and misbranding, Quality systems and CAPA, 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.
IssuedFeb 6, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter ExThera Medical Corporation (Feb 6, 2026)
FDA issued a warning letter to ExThera Medical Corporation concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA). Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, 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.
IssuedFeb 6, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

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Approval Letter ANI PHARMS (Feb 10, 2026)

Approval Letter QOL MEDCL (Feb 10, 2026)

Warning Letter ProDx Health (Feb 10, 2026)

Warning Letter Hearthy Foods, Inc. (Feb 10, 2026)

Warning Letter A TO Z Distributor Inc (Feb 10, 2026)

Approval Letter BAXTER HLTHCARE CORP (Feb 9, 2026)

Warning Letter VeganicSKN Limited (Feb 9, 2026)

Warning Letter Thrive Health and Wellness, LLC dba Thrive Health Solutions (Feb 9, 2026)

Approval Letter CYTOKINETICS (Feb 6, 2026)

Approval Letter PFIZER (Feb 6, 2026)

Warning Letter Cosmetic Manufacturers Pty Ltd. (Feb 6, 2026)

Warning Letter ExThera Medical Corporation (Feb 6, 2026)