FDA 483 - Evergreen Theragnostics, Inc. - February 23, 2023

Evergreen Theragnostics, Inc. in Springfield, NJ, received two observations during an FDA inspection of its testing laboratory for PET drug products. The firm failed to document investigations for out-of-specification results and did not consistently follow written procedures for conducting tests. These issues indicate deficiencies in quality control and laboratory practices related to drug product testing.