# FDA 483 - Integrated Laboratory Systems LLC, An Inotiv Company - September 30, 2022

Source: https://www.globalkeysolutions.net/records/483/integrated-laboratory-systems-llc-an-inotiv-company/75192db2-21e2-4bf0-b145-451914f595cb

> FDA 483 for Integrated Laboratory Systems LLC, An Inotiv Company on September 30, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integrated Laboratory Systems LLC, An Inotiv Company
- Inspection Date: 2022-09-30
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Integrated Laboratory Systems LLC, An Inotiv Company in Morrisville, NC, a nonclinical laboratory, revealed significant deficiencies in their adherence to Good Laboratory Practices. Observations included failures in assuring personnel understanding of functions, inadequate standard operating procedures for various laboratory methods, and a lack of established SOPs for histopathology. These issues indicate a systemic problem with quality and data integrity in their nonclinical studies.

## Related Documents

- [483 - 2024-05-17](https://www.globalkeysolutions.net/records/483/integrated-laboratory-systems-llc-an-inotiv-company/6122a3dd-383f-4406-9130-c8d16a447ef6)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/lynda-lanning/3b6db3e1-32c7-4ff5-9c3f-c20635863535)
- [Betsy C. Galliher](https://www.globalkeysolutions.net/people/betsy-c-galliher/04add63c-cbcb-42f7-b634-7c2925600bef)

Company: https://www.globalkeysolutions.net/companies/integrated-laboratory-systems-llc-an-inotiv-company/942d9fb1-92f1-42bd-ad9c-210ea79aac3a

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7