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

Source: https://www.globalkeysolutions.net/records/483/laboratory-service-inc/ae51e3f9-4f0c-47d1-aaa8-0d2dbc96ad55

> FDA 483 for Laboratory Service Inc. on December 18, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Laboratory Service Inc.
- Inspection Date: 2018-12-18
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.globalkeysolutions.net/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)

Company: https://www.globalkeysolutions.net/companies/laboratory-service-inc/33bbec58-42fb-442e-afe6-06b81be5bf1d

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248