# FDA 483 - GVK Biosciences Pvt. Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/gvk-biosciences-pvt-ltd/f519ec1b-d266-411d-9839-ddc6ae199db0

> FDA 483 for GVK Biosciences Pvt. Ltd. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GVK Biosciences Pvt. Ltd.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Clinogent, a Clinical & Analytical Contract Research Organization in Hyderabad, India, was cited for significant deficiencies during an FDA inspection. The firm failed to establish and follow standard operating procedures for record archival and form accountability, maintain accurate case histories and data, and ensure proper Ethics Committee approval for informed consent forms. These issues indicate a lack of control over critical aspects of clinical and analytical study conduct.

## 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 - 2014-10-09](https://www.keypedia.com/records/483/gvk-biosciences-pvt-ltd/5263bf56-f768-4bd1-8172-22de6d9e4405)

## 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