483
Divyam Institute of Psychiatry dba Divyam HospitalFDA 483 - Divyam Institute of Psychiatry dba Divyam Hospital
Record Details
Divyam Institute of Psychiatry dba Divyam Hospital, a biopharmaceutical clinical testing facility in Palsana, India, was cited for significant deficiencies during a clinical trial inspection. Observations included a lack of evidence for subject eligibility, failure to adhere to protocol-required dosing windows, and unauthorized changes to the protocol's confinement period without proper informed consent. These issues indicate serious concerns regarding data integrity and subject protection.
- Product Type
- Drugs
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ID · 9e304969-a322-49ba-a51f-3a3bb6e88a16