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 1513-1524 of 1819 letters

ALApproval Letter
Approval Letter NOVARTIS (Mar 9, 2026)
FDA posted an approval letter for SANDIMMUNE on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 050573, NDA 050574, NDA 050625 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• SANDIMMUNE
ALApproval Letter
Approval Letter UPSHER SMITH LABS (Mar 9, 2026)
FDA posted an approval letter for QUDEXY XR on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 205122 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• QUDEXY XR
ALApproval Letter
Approval Letter JANSSEN BIOTECH (Mar 9, 2026)
FDA posted an approval letter for ERLEADA on 2026-03-09. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 210951 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 9, 2026
US FDA• ERLEADA
WLWarning Letter
Warning Letter Vedic Lifesciences Pvt. Ltd. (Mar 9, 2026)
FDA issued a warning letter to Vedic Lifesciences Pvt. Ltd. concerning Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Deterministic full-text screening identifies discussion of 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 9, 2026
US FDA• Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies
WLWarning Letter
Warning Letter JZ Wholesale, Inc. (Mar 9, 2026)
FDA issued a warning letter to JZ Wholesale, 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. Topic matches are navigation aids, not a legal conclusion; review the exact FDA web letter and any later response or closeout.
IssuedMar 9, 2026
US FDA• CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
ALApproval Letter
Approval Letter ASTELLAS (Mar 6, 2026)
FDA posted an approval letter for IZERVAY on 2026-03-06. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 217225 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 6, 2026
US FDA• IZERVAY
WLWarning Letter
Warning Letter Middlefield Original Cheese Cooperative (Mar 6, 2026)
FDA issued a warning letter to Middlefield Original Cheese Cooperative concerning CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, 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 6, 2026
US FDA• CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions
WLWarning Letter
Warning Letter Espifresh Inc. (Mar 6, 2026)
FDA issued a warning letter to Espifresh 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 6, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Half Hill Farm Inc. (Mar 6, 2026)
FDA issued a warning letter to Half Hill Farm Inc. concerning Unapproved New Drugs/Misbranded. Deterministic full-text screening identifies discussion of 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 6, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter prilla.com/us (Mar 6, 2026)
FDA issued a warning letter to prilla.com/us 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 6, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
ALApproval Letter
Approval Letter PROVEPHARM SAS (Mar 5, 2026)
FDA posted an approval letter for BAL on 2026-03-05. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 005939 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMar 5, 2026
US FDA• BAL
WLWarning Letter
Warning Letter Life Plus Style Gourmet LLC (Mar 5, 2026)
FDA issued a warning letter to Life Plus Style Gourmet LLC 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 5, 2026
US FDA• Foreign Supplier Verification Program (FSVP)

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Approval Letter NOVARTIS (Mar 9, 2026)

Approval Letter UPSHER SMITH LABS (Mar 9, 2026)

Approval Letter JANSSEN BIOTECH (Mar 9, 2026)

Warning Letter Vedic Lifesciences Pvt. Ltd. (Mar 9, 2026)

Warning Letter JZ Wholesale, Inc. (Mar 9, 2026)

Approval Letter ASTELLAS (Mar 6, 2026)

Warning Letter Middlefield Original Cheese Cooperative (Mar 6, 2026)

Warning Letter Espifresh Inc. (Mar 6, 2026)

Warning Letter Half Hill Farm Inc. (Mar 6, 2026)

Warning Letter prilla.com/us (Mar 6, 2026)

Approval Letter PROVEPHARM SAS (Mar 5, 2026)

Warning Letter Life Plus Style Gourmet LLC (Mar 5, 2026)