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 1813-1819 of 1819 letters

ALApproval Letter
Approval Letter ELI LILLY AND CO (Jan 8, 2026)
FDA posted an approval letter for MOUNJARO (AUTOINJECTOR), MOUNJARO, MOUNJARO KWIKPEN on 2026-01-08. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 215866 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJan 8, 2026
US FDA• MOUNJARO (AUTOINJECTOR) / MOUNJARO / MOUNJARO KWIKPEN
WLWarning Letter
Warning Letter Prodrome Sciences USA, LLC (Jan 8, 2026)
FDA issued a warning letter to Prodrome Sciences USA, LLC concerning Sponsor/Unapproved Misbranded. Deterministic full-text screening identifies discussion of Clinical research and human-subject protections, Quality systems and CAPA, 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.
IssuedJan 8, 2026
US FDA• Sponsor/Unapproved Misbranded
WLWarning Letter
Warning Letter Genovate (Jan 8, 2026)
FDA issued a warning letter to Genovate 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.
IssuedJan 8, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WLWarning Letter
Warning Letter Unomedical Device S.A. de C.V. (Jan 8, 2026)
FDA issued a warning letter to Unomedical Device S.A. de C.V. concerning CGMP/QSR/Medical Devices/Adulterated. Deterministic full-text screening identifies discussion of Quality systems and CAPA, Medical device quality and reporting, Labeling, claims, and misbranding, 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.
IssuedJan 8, 2026
US FDA• CGMP/QSR/Medical Devices/Adulterated
WLWarning Letter
Warning Letter Elanco Animal Health USA (Jan 8, 2026)
FDA issued a warning letter to Elanco Animal Health USA concerning False & Misleading Claims/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.
IssuedJan 8, 2026
US FDA• False & Misleading Claims/Misbranded
WLWarning Letter
Warning Letter Genetrace (Jan 8, 2026)
FDA issued a warning letter to Genetrace 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.
IssuedJan 8, 2026
US FDA• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
WLWarning Letter
Warning Letter Winder Laboratories, LLC (Jan 7, 2026)
FDA issued a warning letter to Winder Laboratories, LLC 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.
IssuedJan 7, 2026
US FDA• CGMP/Finished Pharmaceuticals/Adulterated

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Approval Letter ELI LILLY AND CO (Jan 8, 2026)

Warning Letter Prodrome Sciences USA, LLC (Jan 8, 2026)

Warning Letter Genovate (Jan 8, 2026)

Warning Letter Unomedical Device S.A. de C.V. (Jan 8, 2026)

Warning Letter Elanco Animal Health USA (Jan 8, 2026)

Warning Letter Genetrace (Jan 8, 2026)

Warning Letter Winder Laboratories, LLC (Jan 7, 2026)