# FDA 483 - Medilink Hospital and Research Center - January 21, 2020

Source: https://www.keypedia.com/records/483/medilink-hospital-and-research-center/81a9181f-46d1-4fb6-9b94-d54004c3b616

> FDA 483 for Medilink Hospital and Research Center on January 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medilink Hospital and Research Center
- Inspection Date: 2020-01-21
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Medilink Hospital and Research Centre in Ahmedabad, India, a bioequivalence clinical facility, was cited for failing to conduct foreign clinical studies in accordance with good clinical practice during an inspection from January 15-21, 2020. The inspection revealed multiple instances where subjects were not screened or tested as required by study protocols. This indicates significant deviations in the execution of clinical trials.

## Related Officers

- [Janete F. Guardia](https://www.keypedia.com/people/janete-f-guardia/2405f83f-7ea9-4056-afbd-7d9c00a6e169)

Company: https://www.keypedia.com/companies/medilink-hospital-and-research-center/ee099e0a-12f0-45ec-b980-812bd0a1a44c

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8