FDA 483 - Charles River Laboratories, Inc. DBA Charles River, Endosafe

Charles River Laboratories, Inc., dba Charles River Endosafe in Charleston, SC, a licensed LAL Test Vial and Cartridge Manufacturer, was cited for significant quality system deficiencies during an FDA inspection. Observations included incomplete investigations, manufacturing line failures leading to high rejection rates, and deficient corrective actions. The firm also failed to properly evaluate material changes and process validations, and did not notify the FDA about new product distribution.