FDA 483 - Janssen Pharmaceuticals Inc. - December 14, 2023

Janssen Pharmaceuticals Inc. in Raritan, NJ, was inspected and cited for significant deficiencies in laboratory controls, equipment maintenance, and employee training related to the manufacturing of CARVYKTI product. The inspection revealed issues with unrepresentative sampling plans for final release testing, failure to report biological deviations for distributed product tested with unqualified media, and the use of overdue calibrated or maintained equipment. These findings indicate a lack of adherence to quality standards that could impact product safety, purity, and potency.