FDA 483 - Janssen Biotech Inc. - February 25, 2016

An FDA inspection of Janssen Pharmaceutical Companies of Johnson & Johnson in Horsham, PA, from February 1-25, 2016, revealed significant deficiencies in their quality system. The firm's procedures for handling written and oral drug product complaints were found to be inadequately written or followed, particularly concerning investigations into lack-of-effect complaints and the timely referral of adverse event reports. Additionally, the company lacked developed written procedures for the receipt and reporting of post-marketing adverse drug experiences to the FDA.