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

An FDA inspection conducted at Abbvie Biotechnology Ltd in Barceloneta, PR, from October 17 to October 30, 2023, revealed significant observations related to manufacturing practices for sterile drug products. The primary issue identified was the company's failure to establish and consistently follow procedures designed to prevent microbiological contamination, which is crucial for sterile manufacturing processes.

Specifically, the inspection highlighted a lack of adequate written control procedures detailing operator instructions when an unusual frequency of process interventions occurs during aseptic filling operations. For instance, a non-routine intervention, identified as 30.b, was performed thirteen times in a critical Grade A filling area during the commercial aseptic filling of Risankizumab 150 mg/1.0 mL (Lot 1000490373). This frequency significantly exceeded the intervention's validated frequency as per a media filling study. The firm's Quality Unit did not conduct a necessary process assessment to determine the root cause of this increased intervention rate or implement corrective and preventive actions.

These observations indicate a departure from current Good Manufacturing Practices (GMP) regarding aseptic processing controls. Abbvie Biotechnology Ltd is required to address these findings promptly by developing and implementing robust corrective actions to ensure the sterility assurance of its drug products and prevent recurrence of such deviations.