FDA 483 - Union Agener Inc - December 15, 2023

An FDA inspection of Union Agener Inc, an animal sterile drug manufacturer in Augusta, GA, revealed three significant observations. The firm was cited for inadequate laboratory controls regarding visual inspection for particulates in injectable products, as well as insufficient validation of its aseptic processes, specifically concerning smoke studies. Additionally, deficiencies were noted in the firm's procedures for handling product complaints, including failure to assess retain samples and review previous complaints.