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 1165-1176 of 1819 letters

ALApproval Letter
Approval Letter PARATEK PHARMS (May 15, 2026)
FDA posted an approval letter for NUZYRA on 2026-05-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 209816, NDA 209817 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 15, 2026
US FDA• NUZYRA
ALApproval Letter
Approval Letter BEONE MEDICINES USA (May 15, 2026)
FDA posted an approval letter for BEQALZI on 2026-05-15. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220711 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 15, 2026
US FDA• BEQALZI
WLWarning Letter
Warning Letter vape4sale.com (May 15, 2026)
FDA issued a warning letter to vape4sale.com concerning Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded. Deterministic full-text screening identifies discussion of 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.
IssuedMay 15, 2026
US FDA• Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
WLWarning Letter
Warning Letter Meta Labs Pharmaceuticals, LLC (May 15, 2026)
FDA issued a warning letter to Meta Labs Pharmaceuticals, LLC concerning Dietary Supplement/New Drug/Misbranded. Deterministic full-text screening identifies discussion of Labeling, claims, and misbranding, Manufacturing and CGMP controls, 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.
IssuedMay 15, 2026
US FDA• Dietary Supplement/New Drug/Misbranded
WLWarning Letter
Warning Letter City Market, Inc. (May 15, 2026)
FDA issued a warning letter to City Market, Inc. concerning Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions. Deterministic full-text screening identifies discussion of Food safety and supplier verification, 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.
IssuedMay 15, 2026
US FDA• Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
WLWarning Letter
Warning Letter La Crema De Rebeca (May 14, 2026)
FDA issued a warning letter to La Crema De Rebeca concerning Unapproved New Drugs/Misbranded. 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.
IssuedMay 14, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Bharat Overseas Inc. (May 14, 2026)
FDA issued a warning letter to Bharat Overseas 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.
IssuedMay 14, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter GC America, Inc. (May 14, 2026)
FDA issued a warning letter to GC America, Inc. concerning CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, 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.
IssuedMay 14, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter PolleyMed, LLC (May 14, 2026)
FDA issued a warning letter to PolleyMed, LLC concerning Nonprescription/OTC. 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.
IssuedMay 14, 2026
US FDA• Nonprescription/OTC
WLWarning Letter
Warning Letter Lus Essentials LLC (May 14, 2026)
FDA issued a warning letter to Lus Essentials LLC concerning Unapproved New Drugs/Misbranded. 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.
IssuedMay 14, 2026
US FDA• Unapproved New Drugs/Misbranded
WLWarning Letter
Warning Letter Bushman Organic Farms, Inc. (May 14, 2026)
FDA issued a warning letter to Bushman Organic Farms, 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.
IssuedMay 14, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
ALApproval Letter
Approval Letter MERCK SHARP DOHME (May 13, 2026)
FDA posted an approval letter for KEYTRUDA QLEX on 2026-05-13. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 761467 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAMay 13, 2026
US FDA• KEYTRUDA QLEX

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Approval Letter PARATEK PHARMS (May 15, 2026)

Approval Letter BEONE MEDICINES USA (May 15, 2026)

Warning Letter vape4sale.com (May 15, 2026)

Warning Letter Meta Labs Pharmaceuticals, LLC (May 15, 2026)

Warning Letter City Market, Inc. (May 15, 2026)

Warning Letter La Crema De Rebeca (May 14, 2026)

Warning Letter Bharat Overseas Inc. (May 14, 2026)

Warning Letter GC America, Inc. (May 14, 2026)

Warning Letter PolleyMed, LLC (May 14, 2026)

Warning Letter Lus Essentials LLC (May 14, 2026)

Warning Letter Bushman Organic Farms, Inc. (May 14, 2026)

Approval Letter MERCK SHARP DOHME (May 13, 2026)