Synovo Production, Inc. – FDA 483, Oct 2, 2023

Synovo Production, Inc. in Fullerton, CA, received a Form FDA 483 with five observations following an inspection from September 8 to October 2, 2023. The inspection revealed significant deficiencies in quality system documentation, including undocumented process validation, lack of a design history file, inadequate CAPA documentation, and insufficient supplier qualification. Additionally, the firm failed to document personnel training, with several observations being repeats from a previous Warning Letter.