483
Scitus Pharma Services Pvt LtdScitus Pharma Services Pvt Ltd – FDA 483, Aug 18, 2023
Record Details
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.
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ID · 731b6fff-19e1-460f-8c93-ba08c7fed4b9
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