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 1273-1284 of 1819 letters

WLWarning Letter
Warning Letter Global Imports Origins (Apr 23, 2026)
FDA issued a warning letter to Global Imports Origins 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.
IssuedApr 23, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter jadepouch.com (Apr 23, 2026)
FDA issued a warning letter to jadepouch.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.
IssuedApr 23, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Minh Phung, Inc. (Apr 22, 2026)
FDA issued a warning letter to Minh Phung, Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, 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.
IssuedApr 22, 2026
US FDA• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
WLWarning Letter
Warning Letter Active Cosmetics Manufacturing Inc. (Apr 22, 2026)
FDA issued a warning letter to Active Cosmetics Manufacturing Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Laboratory controls and testing, Manufacturing and CGMP controls, Quality systems and CAPA, 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.
IssuedApr 22, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Estar Technologies Ltd (Apr 22, 2026)
FDA issued a warning letter to Estar Technologies Ltd concerning Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, 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.
IssuedApr 22, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
WLWarning Letter
Warning Letter Boba Factory Inc (Apr 22, 2026)
FDA issued a warning letter to Boba Factory 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.
IssuedApr 22, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
ALApproval Letter
Approval Letter JANSSEN PHARMS (Apr 21, 2026)
FDA posted an approval letter for SPRAVATO on 2026-04-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 211243 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 21, 2026
US FDA• SPRAVATO
ALApproval Letter
Approval Letter MSD (Apr 21, 2026)
FDA posted an approval letter for IDVYNSO on 2026-04-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 216964 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 21, 2026
US FDA• IDVYNSO
ALApproval Letter
Approval Letter BIOGEN (Apr 21, 2026)
FDA posted an approval letter for ZURZUVAE on 2026-04-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217369 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 21, 2026
US FDA• ZURZUVAE
ALApproval Letter
Approval Letter PROVENTION BIO INC (Apr 21, 2026)
FDA posted an approval letter for TZIELD on 2026-04-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761183 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 21, 2026
US FDA• TZIELD
WLWarning Letter
Warning Letter Daily Manufacturing Solutions Inc. (Apr 21, 2026)
FDA issued a warning letter to Daily Manufacturing Solutions Inc. concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of Tobacco product authorization and marketing, 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.
IssuedApr 21, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ALApproval Letter
Approval Letter AZURITY (Apr 20, 2026)
FDA posted an approval letter for DANZITEN on 2026-04-20. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 219293 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAApr 20, 2026
US FDA• DANZITEN

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Warning Letter Global Imports Origins (Apr 23, 2026)

Warning Letter jadepouch.com (Apr 23, 2026)

Warning Letter Minh Phung, Inc. (Apr 22, 2026)

Warning Letter Active Cosmetics Manufacturing Inc. (Apr 22, 2026)

Warning Letter Estar Technologies Ltd (Apr 22, 2026)

Warning Letter Boba Factory Inc (Apr 22, 2026)

Approval Letter JANSSEN PHARMS (Apr 21, 2026)

Approval Letter MSD (Apr 21, 2026)

Approval Letter BIOGEN (Apr 21, 2026)

Approval Letter PROVENTION BIO INC (Apr 21, 2026)

Warning Letter Daily Manufacturing Solutions Inc. (Apr 21, 2026)

Approval Letter AZURITY (Apr 20, 2026)