FDA letter monthly archive

FDA Letters Issued in September 2021

Name: FDA Letters Issued in September 2021
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in September 2021. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter Laboratorios Farmaceuticos Rovi, S.A. (Sep 24, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls, Device constituent and human factors, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 24, 2021
US FDA• RISVAN
CRLComplete Response Letter
Complete Response Letter Verrica Pharmaceuticals Inc. (Sep 16, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 16, 2021
US FDA• YCANTH
CRLComplete Response Letter
Complete Response Letter HQ Specialty Pharma Corporation (Sep 14, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 14, 2021
US FDA• MEROPENEM
CRLComplete Response Letter
Complete Response Letter Zydus Worldwide DMCC (Sep 2, 2021)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, Clinical efficacy and substantial evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedSep 2, 2021
US FDA• ZITUVIO

Complete Response Letter Laboratorios Farmaceuticos Rovi, S.A. (Sep 24, 2021)

Complete Response Letter Verrica Pharmaceuticals Inc. (Sep 16, 2021)

Complete Response Letter HQ Specialty Pharma Corporation (Sep 14, 2021)

Complete Response Letter Zydus Worldwide DMCC (Sep 2, 2021)