483
Namita A. Goyal, M.D.Namita A. Goyal, M.D. – FDA 483, Jun 23, 2023
Record Details
An FDA inspection of Namita A. Goyal, M.D. in Orange, CA, revealed multiple significant deficiencies in the conduct of clinical trials. The firm failed to adhere to the signed investigator statement, obtain legally effective informed consent, and promptly report serious adverse events. Additionally, the inspection found issues with obtaining IRB approval for research changes and maintaining adequate and accurate case histories.
View Company Profile
ID · e7e5de0d-a580-41b5-a6c4-0fb7c7552ce3
Other documents for Namita A. Goyal, M.D.
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.