Janssen Pharmaceuticals Inc. – FDA EIR, Jan 26, 2017

This FDA surveillance inspection of Janssen Pharmaceuticals, Inc.'s Raritan, NJ facility took place from January 23 to January 26, 2017. The inspection focused on the company's control testing laboratory for pharmaceuticals, specifically its stability testing operations for drug products. The assessment provided Good Manufacturing Practice (GMP) coverage, adhering to the regulatory framework for Drug Manufacturing Inspections (CP7356.002), and was conducted jointly with Health Canada.

Over the four-day period, the inspection thoroughly evaluated the Quality and Laboratory Control systems. This review included examining areas such as laboratory and stability chamber operations, sample handling procedures, laboratory events, invalid assays, change controls, corrective and preventative actions (CAPAs), and various laboratory equipment. Notably, the inspection concluded without identifying any deficiencies or objectionable conditions. Consequently, the FDA investigator did not issue an FDA-483, Inspectional Observations. The Health Canada inspector also reported no critical observations.

As no violations or deficiencies were found, there were no required corrective actions for Janssen Pharmaceuticals, Inc. to implement following this inspection. The firm's drug registration was also confirmed as current.