# FDA 483 - Inotiv, Inc. - May 23, 2025

Source: https://www.keypedia.com/records/483/inotiv-inc/f1e7758e-cb7f-4181-a734-2a764c5e93fa

> FDA 483 for Inotiv, Inc. on May 23, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inotiv, Inc.
- Inspection Date: 2025-05-23
- Product Type: other
- Office Name: Detroit District Office
- Summary: Inotiv, Inc. in Mount Vernon, IN, a nonclinical laboratory, was cited with five observations during an FDA inspection. The observations primarily concern significant deficiencies in Good Laboratory Practice (GLP) studies, including failures in timely archiving of study materials, inaccurate quality assurance statements, incomplete final study reports, and inconsistent specimen identification. These issues indicate a lack of robust data integrity and quality control within their nonclinical laboratory operations.

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## Related Officers

- [investigator](https://www.keypedia.com/people/corrine-m-carter/69e1be8c-1cd9-48d9-a08e-bf49060b94d6)
- [investigator](https://www.keypedia.com/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)

Company: https://www.keypedia.com/companies/inotiv-inc/5dacc898-d407-40c0-b108-c4702119add1

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03