# FDA 483 - GVK Biosciences Pvt. Ltd. - October 09, 2014

Source: https://www.keypedia.com/records/483/gvk-biosciences-pvt-ltd/5263bf56-f768-4bd1-8172-22de6d9e4405

> FDA 483 for GVK Biosciences Pvt. Ltd. on October 09, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GVK Biosciences Pvt. Ltd.
- Inspection Date: 2014-10-09
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Clinogent (A Division of GVK Biosciences Pvt. Ltd.) in Ameerpet, Hyderabad, India, a Clinical & Analytical Contract Research Organization, was cited with three observations during an FDA inspection. The inspection revealed significant issues with standard operating procedures, including improper record archival and form accountability, as well as failures in maintaining accurate case histories and data. Additionally, the firm failed to obtain Ethics Committee approval for a study-specific informed consent form.

## Related Documents

- [EIR - 2011-03-30](https://www.keypedia.com/records/eir/gvk-biosciences-pvt-ltd/1aeb9e45-53b5-4ee5-9c26-82ec3504b9d7)
- [EIR - 2014-10-09](https://www.keypedia.com/records/eir/gvk-biosciences-pvt-ltd/e8a83dcb-d2d7-4e8b-89e7-85656fd65f9f)
- [EIR - 2015-03-13](https://www.keypedia.com/records/eir/gvk-biosciences-pvt-ltd/38382408-3fb3-4cd1-9e50-c3dcbbfb054d)
- [483 - 2015-03-13](https://www.keypedia.com/records/483/gvk-biosciences-pvt-ltd/5f43791a-4ab0-45af-9712-99c86ae216de)
- [483 - Unknown Date](https://www.keypedia.com/records/483/gvk-biosciences-pvt-ltd/f519ec1b-d266-411d-9839-ddc6ae199db0)

## Related Officers

- [Senior Advisor, Office of Study Integrity and Surveillance](https://www.keypedia.com/people/sam-haidar/658889fd-f946-4811-b3f5-7651cc6ce660)
- [investigator](https://www.keypedia.com/people/scott-b-laufenberg/ff95c69f-5ee2-4761-b4ef-8b8137c3d963)

Company: https://www.keypedia.com/companies/gvk-biosciences-pvt-ltd/b9655de8-c18d-4572-9f8b-252e9ea89352

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