Issued: 2/1/12
Region: Central
Category: Device 483s
Inspection date range: 1/20/12-2/1/12
Pages: 2
Company: Arrow International, Inc.
2 Berry Dr.
Mount Jolly, NJ 08060
Inspector(s): Loretta Nemchik
Observations: A validated process was not reviewed and evaluated when changes or process deviations occurred.