# FDA 483 - ZenRise Clinical Research Pvt., Ltd - January 20, 2023

Source: https://www.keypedia.com/records/483/zenrise-clinical-research-pvt-ltd/68241eda-5019-4f73-ba8b-55d81cc0a323

> FDA 483 for ZenRise Clinical Research Pvt., Ltd on January 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZenRise Clinical Research Pvt., Ltd
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: ZenRise Clinical Research Pvt., Ltd. in Hyderabad, India, was inspected from January 16-20, 2023, and cited for significant deficiencies in conducting clinical bioequivalence studies. The observations include failures in reporting adverse events, maintaining complete and accurate records, and proper investigational product accountability. These issues indicate a lack of adherence to Good Clinical Practices.

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Company: https://www.keypedia.com/companies/zenrise-clinical-research-pvt-ltd/700de278-23b2-4564-8812-238f821f636d

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321