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 1237-1248 of 1503 letters

ALApproval Letter
Approval Letter JANSSEN PRODS (Mar 3, 2026)
FDA issued an approval letter for PREZCOBIX on 2026-03-03. The source metadata identifies NDA 205395 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• PREZCOBIX
ALApproval Letter
Approval Letter TEVA PHARMS USA (Mar 3, 2026)
FDA issued an approval letter for FLUOROURACIL on 2026-03-03. The source metadata identifies ANDA 040333, ANDA 040334 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 3, 2026
US FDA• FLUOROURACIL
WLWarning Letter
Warning Letter Fareva Morton Grove (Mar 3, 2026)
FDA issued a warning letter to Fareva Morton Grove 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.
IssuedMar 3, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Ocean Group Inc. (Mar 3, 2026)
FDA issued a warning letter to Ocean Group Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, Quality systems and CAPA, Manufacturing and CGMP controls, 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 3, 2026
US FDA• Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
WLWarning Letter
Warning Letter Simtra BioPharma Solutions (Mar 3, 2026)
FDA issued a warning letter to Simtra BioPharma Solutions concerning CGMP/Finished Pharmaceuticals/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 3, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Barcelona Nut Company Inc. (Mar 3, 2026)
FDA issued a warning letter to Barcelona Nut Company Inc. concerning CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/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.
IssuedMar 3, 2026
US FDA• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
WLWarning Letter
Warning Letter Tentamus India Private Limited (Mar 3, 2026)
FDA issued a warning letter to Tentamus India Private Limited concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Data integrity and records, 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 3, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
ALApproval Letter
Approval Letter ARGENX BV (Mar 2, 2026)
FDA issued an approval letter for VYVGART HYTRULO on 2026-03-02. The source metadata identifies BLA 761304 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 2, 2026
US FDA• VYVGART HYTRULO
ALApproval Letter
Approval Letter GENSCO (Mar 2, 2026)
FDA issued an approval letter for RIZAFILM on 2026-03-02. The source metadata identifies NDA 205394 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 2, 2026
US FDA• RIZAFILM
ALApproval Letter
Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026)
FDA issued an approval letter for JASCAYD on 2026-03-02. The source metadata identifies NDA 218764 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 2, 2026
US FDA• JASCAYD
ALApproval Letter
Approval Letter XCOVERY (Mar 2, 2026)
FDA issued an approval letter for ENSACOVE on 2026-03-02. The source metadata identifies NDA 218171 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 2, 2026
US FDA• ENSACOVE
ALApproval Letter
Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026)
FDA issued an approval letter for HERNEXEOS on 2026-03-02. The source metadata identifies NDA 219042 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedMar 2, 2026
US FDA• HERNEXEOS

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Approval Letter JANSSEN PRODS (Mar 3, 2026)

Approval Letter TEVA PHARMS USA (Mar 3, 2026)

Warning Letter Fareva Morton Grove (Mar 3, 2026)

Warning Letter Ocean Group Inc. (Mar 3, 2026)

Warning Letter Simtra BioPharma Solutions (Mar 3, 2026)

Warning Letter Barcelona Nut Company Inc. (Mar 3, 2026)

Warning Letter Tentamus India Private Limited (Mar 3, 2026)

Approval Letter ARGENX BV (Mar 2, 2026)

Approval Letter GENSCO (Mar 2, 2026)

Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026)

Approval Letter XCOVERY (Mar 2, 2026)

Approval Letter BOEHRINGER INGELHEIM (Mar 2, 2026)