FDA 483 - Janssen Ortho LLC - May 26, 2017

The FDA inspection of Janssen Ortho L.L.C. in Gurabo, PR, revealed significant deficiencies across multiple systems, including quality, laboratory, facilities, equipment, and production. Key issues involved inadequate investigations into product discrepancies, deficient complaint handling, poor data integrity practices, and failures in equipment calibration and cleaning procedures. These findings collectively indicate a systemic lack of adherence to cGMP requirements, posing a moderate risk to product quality and patient safety.