# FDA 483 - GVK Biosciences Pvt. Ltd. - March 13, 2015

Source: https://www.globalkeysolutions.net/records/483/gvk-biosciences-pvt-ltd/5f43791a-4ab0-45af-9712-99c86ae216de

> FDA 483 for GVK Biosciences Pvt. Ltd. on March 13, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GVK Biosciences Pvt. Ltd.
- Inspection Date: 2015-03-13
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Clinogent (Div of GVK Biosciences) in Hyderabad, India, a Clinical Pharmacological Unit, revealed significant deficiencies in record-keeping and study documentation. Observations included issues with electronic ECG records, lack of adverse event evaluations, missing drug screening assay information, and inadequate maintenance of correspondence files. These findings highlight concerns regarding data integrity and the proper conduct of clinical studies.

## Related Documents

- [EIR - 2011-03-30](https://www.globalkeysolutions.net/records/eir/gvk-biosciences-pvt-ltd/1aeb9e45-53b5-4ee5-9c26-82ec3504b9d7)
- [EIR - 2014-10-09](https://www.globalkeysolutions.net/records/eir/gvk-biosciences-pvt-ltd/e8a83dcb-d2d7-4e8b-89e7-85656fd65f9f)
- [EIR - 2015-03-13](https://www.globalkeysolutions.net/records/eir/gvk-biosciences-pvt-ltd/38382408-3fb3-4cd1-9e50-c3dcbbfb054d)
- [483 - 2014-10-09](https://www.globalkeysolutions.net/records/483/gvk-biosciences-pvt-ltd/5263bf56-f768-4bd1-8172-22de6d9e4405)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/gvk-biosciences-pvt-ltd/f519ec1b-d266-411d-9839-ddc6ae199db0)

## Related Officers

- [Theressa B. Smith](https://www.globalkeysolutions.net/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

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

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