FDA 483 - Abbvie Biotechnology Ltd. - October 30, 2023

An FDA inspection of Abbvie Biotechnology Ltd in Barceloneta, PR, from October 17-30, 2023, revealed deficiencies in procedures designed to prevent microbiological contamination of sterile drug products. The firm failed to establish and follow adequate written control procedures for handling unusual frequencies of process interventions during aseptic filling operations. This included a specific instance where an unexpected increase in a non-routine intervention was not assessed by the Quality Unit.