Janssen Biotech, Inc.: amivantamab hyaluronidase

, FDA identified deficiencies and communicated them to the representative of the facility.

The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA Form 483 prior to resubmitting your application for amivantamab and hyaluronidase injection.

Your complete response addressing these deficiencies must include the date of the facility's response to the FDA Form 483. The assessment of the application approvability and the resolution of inspection deficiencies will be evaluated upon receipt of the complete response addressing the deficiencies and may include reinspection of the facility.

(7) | Currently, FDA's pharmacokinetic and immunogenicity assessment is contingent upon full evaluation of the data quality and integrity of sample analysis.