This section contains information specific to the US region, including the executed batch records for the PPQ lots of the drug substance and drug product. In response to observations noted during the pre-license inspection (PLI) conducted from August 21-25, 2017, a summary of corrective and preventive actions (CAPAs) is also included. We also include a postmarketing commitment to develop and validate additional tests for particulate matter for the Drug Product and Diluent.