Complete Response Letters
Fresenius Kabi USA, LLC: MSB11456
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Feb 27, 2026
No complete sentence from this letter is available from the knowledge graph yet.
Complete Response Letter, Feb 27, 2026
No complete sentence from this letter is available from the knowledge graph yet.
Complete Response Letter, Apr 25, 2025
No complete sentence from this letter is available from the knowledge graph yet.
Complete Response Letter, Dec 11, 2024
, which constituted a complete response to ou action letter.
CRL_NDA214610_20241211:p1:s13We acknowledge receipt of your major amendment dated , which extended the goal date by three months.
CRL_NDA214610_20241211:p1:s14Complete Response Letter, May 31, 2023
Following inspections of Fresenius Kabi Austria GmbH, Graz, Austria (FEI: 3003708554) and ®® listed in this application, FDA conveyed deficiencies to the representative of the facility.
CRL_BLA761275_20230531:p1:s17Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_BLA761275_20230531:p1:s181. Revise the method for container closure integrity testing of MSB11456 drug product in vial to include a positive control that reflects a breach defect < 20 um and update the application accordingly.
CRL_BLA761275_20230531:p2:s8More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.