# Kanoria Hospital and Research Centre – FDA 483

Source: https://www.keypedia.com/records/483/kanoria-hospital-and-research-centre/27e186be-d2bc-44db-8c87-67758e96406d

> FDA 483 for Kanoria Hospital and Research Centre on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kanoria Hospital and Research Centre
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of Kanoria Hospital and Research Centre in Ahmedabad, India, revealed significant deficiencies in the conduct of a bioequivalence clinical study. Observations included a failure to ensure data credibility and accuracy due to highly similar vital sign results and repeated patterns in study assessments. Additionally, the firm failed to follow its investigation plan by enrolling subjects from the same household and allowing concurrent participation.

## Related Officers

- [Andrace Deyampert](https://www.keypedia.com/people/andrace-deyampert/cdb4f833-488b-42b9-abab-4216435bce4c)

Company: https://www.keypedia.com/companies/kanoria-hospital-and-research-centre/dd15b2f7-6006-4819-a021-a2693d52814c

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917