FDA letter monthly archive

FDA Letters Issued in September 2017

Name: FDA Letters Issued in September 2017
Creator: Assyro AI
License: https://www.usa.gov/government-works

Browse FDA application-action, complete response, and warning letters issued in September 2017. Each result links to a structured letter page with source-document access, metadata, and regulatory intelligence summaries.

CRLComplete Response Letter
Complete Response Letter B. Braun Medical, Inc. (Sep 28, 2017)
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 28, 2017
US FDA• ACETAMINOPHEN
CRLComplete Response Letter
Complete Response Letter Actavis, L.L.C. (Sep 26, 2017)
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 26, 2017
US FDA• PEMETREXED

Complete Response Letter B. Braun Medical, Inc. (Sep 28, 2017)

Complete Response Letter Actavis, L.L.C. (Sep 26, 2017)