FDA 483 - Laboratory Service Inc. - December 18, 2018

This FDA Form 483 report details significant deficiencies at Laboratory Service Inc. in Carteret, NJ, a contract laboratory. The inspection revealed severe issues with data integrity, including inadequate computer system controls, a lack of data backup procedures leading to data loss, and insufficient laboratory controls for Gas Chromatography analyses. These observations indicate a systemic failure to ensure the reliability and integrity of laboratory data and testing processes.