FDA letter monthly archive

FDA Letters Issued in June 2024

Name: FDA Letters Issued in June 2024
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in June 2024. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter CELLTRION, Inc. (Jun 27, 2024)
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 27, 2024
US FDA• EYDENZELT
CRLComplete Response Letter
Complete Response Letter Daiichi Sankyo, Inc. (Jun 26, 2024)
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.
IssuedJun 26, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter Nanocopoeia, LLC (Jun 14, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance, Safety and adverse events. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 14, 2024
US FDA• CAVHANZA
CRLComplete Response Letter
Complete Response Letter Rocket Pharmaceuticals, Inc. (Jun 14, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 14, 2024
US FDA• marnetegragene autotemcel
CRLComplete Response Letter
Complete Response Letter Bayer HealthCare LLC (Jun 13, 2024)
FDA's complete response letter contains source-text evidence related to Facility inspection and CGMP compliance, Labeling, packaging, and proprietary name, Nonclinical evidence. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 13, 2024
US FDA• Unknown
CRLComplete Response Letter
Complete Response Letter XTM Consulting LLC (Jun 12, 2024)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedJun 12, 2024
US FDA• LOPRESSOR

Complete Response Letter CELLTRION, Inc. (Jun 27, 2024)

Complete Response Letter Daiichi Sankyo, Inc. (Jun 26, 2024)

Complete Response Letter Nanocopoeia, LLC (Jun 14, 2024)

Complete Response Letter Rocket Pharmaceuticals, Inc. (Jun 14, 2024)

Complete Response Letter Bayer HealthCare LLC (Jun 13, 2024)

Complete Response Letter XTM Consulting LLC (Jun 12, 2024)