# FDA 483 - Divyam Institute of Psychiatry dba Divyam Hospital - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/divyam-institute-of-psychiatry-dba-divyam-hospital/9e304969-a322-49ba-a51f-3a3bb6e88a16

> FDA 483 for Divyam Institute of Psychiatry dba Divyam Hospital on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Divyam Institute of Psychiatry dba Divyam Hospital
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [Assistant Country Director, Regulatory Specialist BIMO](https://www.globalkeysolutions.net/people/alanna-l-mussawwir-bias/1283ff1a-34dd-4d90-9389-7bff2570527d)

Company: https://www.globalkeysolutions.net/companies/divyam-institute-of-psychiatry-dba-divyam-hospital/5976a1c9-4d79-4c9a-8b59-1caba9f99138

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd