# FDA 483 - Scott Health Services LLC - July 22, 2019

Source: https://www.globalkeysolutions.net/records/483/scott-health-services-llc/882a1de9-e3b0-4881-a068-9a5bd75bf930

> FDA 483 for Scott Health Services LLC on July 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scott Health Services LLC
- Inspection Date: 2019-07-22
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Scott Health Services, LLC in New Albany, Indiana, revealed a significant deficiency in their clinical trial practices. The firm failed to retain samples of investigational drug product and reference standards used in a bioequivalence study, specifically from a shipment received in July 2018. This lapse prevents the FDA from requesting and analyzing these critical samples as required for regulatory compliance.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/karen-m-cooper/4813e60d-c8da-4df2-bc48-ecfb06a55cf8)

Company: https://www.globalkeysolutions.net/companies/scott-health-services-llc/0da124e0-6bd7-4cbb-b1d5-e6c61890cda1

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0