483
Advity Research Private, LimitedAdvity Research Private, Limited – FDA 483, Mar 15, 2024
Record Details
An FDA inspection of Advity Research Pvt., Ltd. in Kukatpally, India, a clinical and bioanalytical biopharmaceutical research facility, revealed a significant issue regarding informed consent. The firm failed to meet general requirements for informed consent, specifically by including language in their forms that did not minimize the possibility of coercion or undue influence. This observation indicates a moderate severity issue related to subject protection in clinical trials.
View Company Profile
ID · ebabd9ed-a366-4a4d-aedb-c128ae02bf3d
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.