FDA letter monthly archive

FDA Letters Issued in December 2023

Name: FDA Letters Issued in December 2023
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in December 2023. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter CooperSurgical, Inc. (Dec 18, 2023)
FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Safety and adverse events, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 18, 2023
US FDA• PARAGARD T 380A
CRLComplete Response Letter
Complete Response Letter Checkpoint Therapeutics, Incorporated (Dec 15, 2023)
FDA's complete response letter contains source-text evidence related to Chemistry, manufacturing, and controls, Facility inspection and CGMP compliance. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
IssuedDec 15, 2023
US FDA• UNLOXCYT

Complete Response Letter CooperSurgical, Inc. (Dec 18, 2023)

Complete Response Letter Checkpoint Therapeutics, Incorporated (Dec 15, 2023)