# FDA 483 - Integrated Laboratory Systems LLC, An Inotiv Company - May 17, 2024

Source: https://www.globalkeysolutions.net/records/483/integrated-laboratory-systems-llc-an-inotiv-company/6122a3dd-383f-4406-9130-c8d16a447ef6

> FDA 483 for Integrated Laboratory Systems LLC, An Inotiv Company on May 17, 2024. Product: other. 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: 2024-05-17
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: Integrated Laboratory Systems LLC, An Inotiv Company in Morrisville, NC, a nonclinical laboratory, was issued a Form 483 following an FDA inspection. The inspection revealed significant deficiencies related to inadequate standard operating procedures for nonclinical studies, failure to promptly replace a study director, and the quality assurance unit's failure to document protocol deviations. These issues indicate potential concerns regarding data quality and integrity in their studies.

## Related Documents

- [483 - 2022-09-30](https://www.globalkeysolutions.net/records/483/integrated-laboratory-systems-llc-an-inotiv-company/75192db2-21e2-4bf0-b145-451914f595cb)

## Related Officers

- [other](https://www.globalkeysolutions.net/people/erin-m-mcdowell/7f3995e6-5596-4b3a-a99b-27d49d4b890e)
- [investigator](https://www.globalkeysolutions.net/people/anthony-j-grace/023993d4-63ef-40ba-a538-42479b65011c)

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

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64