# Scitus Pharma Services Pvt Ltd – FDA 483, Aug 18, 2023

Source: https://www.keypedia.com/records/483/scitus-pharma-services-pvt-ltd/731b6fff-19e1-460f-8c93-ba08c7fed4b9

> FDA 483 for Scitus Pharma Services Pvt Ltd on August 18, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scitus Pharma Services Pvt Ltd
- Inspection Date: 2023-08-18
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Scitus Pharma Services Pvt Ltd in Chennai, India, revealed a significant issue with informed consent practices. The firm failed to minimize the possibility of coercion or undue influence during the consent process for a clinical study, specifically by including a misleading statement in the informed consent forms. This indicates a serious deficiency in protecting the rights and welfare of human subjects.

## Related Officers

- [Investigator](https://www.keypedia.com/people/lori-gioia/34b9339b-0bd2-4e41-8da1-b445ad829e53)

Company: https://www.keypedia.com/companies/scitus-pharma-services-pvt-ltd/c13c0eac-206f-48d7-bbca-089d96a89d20

Office: https://www.keypedia.com/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4