FDA 483 - Laboratory Service Inc. - December 18, 2018
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · ae51e3f9-4f0c-47d1-aaa8-0d2dbc96ad55