FDA 483 - Charles River Laboratories, Inc. DBA Charles River, Endosafe - January 13, 2016

Charles River Laboratories, Inc. dba Charles River Endosafe in Charleston, SC, a licensed LAL Test Vial and Cartridge Manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate aseptic processing controls, including media fills, environmental monitoring, cleaning procedures for the Class 100 fill room and equipment, and validation of critical processes like smoke studies and expiration dating. These issues indicate a lack of control over manufacturing processes that could impact product quality and sterility.