FDA 483 - Janssen Cilag Manufacturing LLC - February 11, 2026

Janssen Cilag Manufacturing LLC in Gurabo, PR, received a Form 483 with two observations related to inadequate quality control. The firm failed to establish scientifically sound sampling plans and test procedures for drug product release and did not thoroughly investigate unexplained product discrepancies, including a previously observed deficiency. These issues indicate significant concerns with the firm's laboratory controls and quality system.