Sabratek purchasing controls for pre-filled syringes inadequate, FDA says in Dec. 12 warning letter.
This article was originally published in The Gray Sheet
Executive Summary
SABRATEK PURCHASING CONTROLS FOR IV FLUSH SYRINGES INADEQUATE, FDA SAYS in a Dec. 12 warning letter to the company. The agency cites Sabratek's Woburn, Massachusetts-based Rocap facility for failing to test incoming products such as syringe, heparin injection, and saline injection components. In addition, "suppliers of incoming product are neither audited nor under any written agreement." The warning letter follows an inspection conducted between Aug. 28 and Sept. 29.