Complete Response Letters
UGB, Inc.: UCB4940
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, May 12, 2022
We acknowledge receipt of your major amendment dated April 16, 2021, which extended the goal date by three months.
CRL_BLA761151_20220512:p1:s14During a recent inspection of the UCB Pharma SA (FEI: 3003909356) manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.
CRL_BLA761151_20220512:p1:s19Satisfactory resolution of these deficiencies is required before this application may be approved.
CRL_BLA761151_20220512:p1:s20(8) Provide English translations of current approved foreign labeling not previously submitted.
CRL_BLA761151_20220512:p1:s46More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.