FDA 483 - AbbVie Ltd - February 20, 2020

AbbVie LTD in Barceloneta, PR, was inspected from February 5-20, 2020, revealing significant deficiencies in production, process controls, cleaning procedures, and laboratory record-keeping. The inspection, which included a Pre-Approval Inspection for Elagolix/Estradiol/Norethindrone Acetate and a Post-Approval Inspection for Synthroid Tablets, identified a lack of adequate written procedures, incomplete batch records, insufficient cleaning validation, and incomplete laboratory data. These findings indicate a need for comprehensive improvements in the firm's quality systems to ensure drug product quality and purity.