Complete Response Letters
Evergreen Theragnostics, Inc.: NDA 216900
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 26, 2026
We acknowledge receipt of your major amendment dated March 11, 2026, which extended the goal date by three months.
CRL_NDA216900_20260626:p1:s16, aS listed in this application, FDA conveyed deficiencies to the representative of the facility.
CRL_NDA216900_20260626:p1:s37The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response.
CRL_NDA216900_20260626:p1:s38The facility's satisfactory responses are dependent on FDA's determination that the facility has come into compliance with CGMP and may require reinspection of the facility.
CRL_NDA216900_20260626:p1:s39FDA may need to conduct a pre-approval inspection (PAI) of the facility.
CRL_NDA216900_20260626:p1:s44More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.