FDA 483 - Boston Scientific Corporation - May 20, 2005

The FDA Form 483 inspection of BSC Quincy revealed significant deficiencies in their quality system and manufacturing controls. The organizational structure is inadequate, failing to control inventory activities (sale, shipment, receipt, control, return) through proper personnel actions, documentation, and procedures.

A critical finding was the inadequate control of nonconforming products. Specifically, units of Taxus Express 2 (Batch REDACTED) that failed initial KDR testing were shipped while on "Pending KDR Test Results ship hold." Additionally, three shipments of Vaxcel Low Profile Ports were made after a ship hold was received on 8/25/04, with products sold or sampled by sales representatives on 9/21/04, 12/14/04, and 2/15/2005.

Documentation of nonconforming product disposition was absent, as BSC Quincy closed ship hold 04-08-018 without accounting for sales representative "Trunk Stock" that was part of the original hold.

Corrective and preventive action (CAPA) activities were not adequately documented. Multiple CAPAs (05-004, 04-052, 04-082, 04-120, 05-013) lacked necessary details regarding non-conforming conditions, actual occurrence dates, involved personnel, quantities, and product identification. Email discussions