FDA 483 - Alcami Carolinas Corporation - March 13, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 65e0e803-2088-4ee7-92bb-6fbb49859cfd