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 757-768 of 1503 letters

ALApproval Letter
Approval Letter HAISCO PHARMACEUTICAL GROUP CO LTD (Jun 2, 2026)
FDA issued an approval letter for CIPEPOFOL on 2026-06-02. The source metadata identifies NDA 220482 as an original application. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 2, 2026
US FDA• CIPEPOFOL
ALApproval Letter
Approval Letter GILEAD SCIENCES INC (Jun 2, 2026)
FDA issued an approval letter for BIKTARVY on 2026-06-02. The source metadata identifies NDA 210251 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 2, 2026
US FDA• BIKTARVY
ALApproval Letter
Approval Letter MANNKIND (Jun 2, 2026)
FDA issued an approval letter for AFREZZA on 2026-06-02. The source metadata identifies BLA 022472 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
IssuedJun 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 source-metadata 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 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.
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 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.
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 source-metadata 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
WLWarning Letter
Warning Letter Erkul Kozmetik Sanayi ve Ticaret A.S. (Jun 2, 2026)
FDA issued a warning letter to Erkul Kozmetik Sanayi ve Ticaret A.S. concerning CGMP/OTC Finished Pharmaceuticals/Adulterated. Deterministic full-text screening identifies discussion of 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.
IssuedJun 2, 2026
US FDA• CGMP/OTC Finished Pharmaceuticals/Adulterated
WLWarning Letter
Warning Letter Revlon Group Holdings, LLC (Jun 2, 2026)
FDA issued a warning letter to Revlon Group Holdings, LLC concerning CGMP/OTC 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.
IssuedJun 2, 2026
US FDA• CGMP/OTC Finished Pharmaceuticals/Adulterated

Page 64 of 126

1…62 63 64 65 66…126

Approval Letter HAISCO PHARMACEUTICAL GROUP CO LTD (Jun 2, 2026)

Approval Letter GILEAD SCIENCES INC (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)

Warning Letter Erkul Kozmetik Sanayi ve Ticaret A.S. (Jun 2, 2026)

Warning Letter Revlon Group Holdings, LLC (Jun 2, 2026)