FDA 483 - Alcami Carolinas Corporation - March 13, 2023

An FDA inspection of Alcami Carolinas Corporation in Durham, NC, a contract manufacturer and testing laboratory, revealed two significant observations. The firm failed to thoroughly review unexplained discrepancies in batch records, including issues with actual yield specifications and justifications for variations in sterile injectable drug product manufacturing. Additionally, drug product samples were not properly identified, and the firm's SOP for sample handling was found to be deficient.