FDA 483 - Divyam Institute of Psychiatry dba Divyam Hospital

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.