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 1069-1080 of 1819 letters

TATentative Approval Letter
Tentative Approval Letter ALKEM LABS LTD (Jun 2, 2026)
FDA posted a tentative approval letter for SITAGLIPTIN PHOSPHATE on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 215155 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• SITAGLIPTIN PHOSPHATE
ALApproval Letter
Approval Letter ARMSTRONG PHARMS (Jun 2, 2026)
FDA posted an approval letter for IPRATROPIUM BROMIDE on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217953 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• IPRATROPIUM BROMIDE
ALApproval Letter
Approval Letter NOVARTIS (Jun 2, 2026)
FDA posted an approval letter for AFINITOR, AFINITOR DISPERZ on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 022334, NDA 203985 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• AFINITOR / AFINITOR DISPERZ
ALApproval Letter
Approval Letter HAISCO (Jun 2, 2026)
FDA posted an approval letter for CYPSEDO on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220482 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• CYPSEDO
ALApproval Letter
Approval Letter MANNKIND (Jun 2, 2026)
FDA posted an approval letter for AFREZZA on 2026-06-02. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies BLA 022472 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Posted by FDAJun 2, 2026
US FDA• AFREZZA
WLWarning Letter
Warning Letter M G R Produce LLC (Jun 2, 2026)
FDA issued a warning letter to M G R Produce 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.
IssuedJun 2, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter PLZ Corp (Jun 2, 2026)
FDA issued a warning letter to PLZ Corp concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text 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.
IssuedJun 2, 2026
US FDA• CGMP/OTC Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Gopaldas Visram & Co., Ltd. (Jun 2, 2026)
FDA issued a warning letter to Gopaldas Visram & Co., Ltd. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Laboratory controls and testing, Quality systems and CAPA, 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.
IssuedJun 2, 2026
US FDA• CGMP/OTC Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter SL Follen Company (Jun 2, 2026)
FDA issued a warning letter to SL Follen Company 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.
IssuedJun 2, 2026
US FDA• Foreign Supplier Verification Program (FSVP)
WLWarning Letter
Warning Letter Zydus Lifesciences Limited (Jun 2, 2026)
FDA issued a warning letter to Zydus Lifesciences Limited concerning Request for Records/CGMP/Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of Manufacturing and CGMP controls, Data integrity and records, Laboratory controls and testing, 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.
IssuedJun 2, 2026
US FDA• Request for Records/CGMP/Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Umendra Life Sciences Private Limited (Jun 2, 2026)
FDA issued a warning letter to Umendra Life Sciences Private Limited concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text 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.
IssuedJun 2, 2026
US FDA• CGMP/OTC Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Shantou Qiwei Industry Co., LTD (Jun 2, 2026)
FDA issued a warning letter to Shantou Qiwei Industry Co., LTD concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text 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.
IssuedJun 2, 2026
US FDA• CGMP/OTC Finished Pharmaceuticals/Adulterated

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Tentative Approval Letter ALKEM LABS LTD (Jun 2, 2026)

Approval Letter ARMSTRONG PHARMS (Jun 2, 2026)

Approval Letter NOVARTIS (Jun 2, 2026)

Approval Letter HAISCO (Jun 2, 2026)

Approval Letter MANNKIND (Jun 2, 2026)

Warning Letter M G R Produce LLC (Jun 2, 2026)

Warning Letter PLZ Corp (Jun 2, 2026)

Warning Letter Gopaldas Visram & Co., Ltd. (Jun 2, 2026)

Warning Letter SL Follen Company (Jun 2, 2026)

Warning Letter Zydus Lifesciences Limited (Jun 2, 2026)

Warning Letter Umendra Life Sciences Private Limited (Jun 2, 2026)

Warning Letter Shantou Qiwei Industry Co., LTD (Jun 2, 2026)