# FDA 483 - Citrogein (Div of GVK Biosciences) - March 13, 2015

Source: https://www.globalkeysolutions.net/records/483/citrogein-div-of-gvk-biosciences/fb6d2324-28e5-4fde-bd0d-a19519e9f2a8

> FDA 483 for Citrogein (Div of GVK Biosciences) on March 13, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Citrogein (Div of GVK Biosciences)
- Inspection Date: 2015-03-13
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Citrogein (Div of GVK Biosciences), a Clinical Pharmacological Unit in Hyderabad, India, revealed significant issues with data integrity and record-keeping practices. Observations included discrepancies in electronic ECG records, lack of documentation for adverse event evaluations during study wash-out periods, and missing information regarding drug screening assay systems. Additionally, the firm failed to maintain complete correspondence files between the clinical site and the sponsor.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/citrogein-div-of-gvk-biosciences/018f9ac5-71ad-433c-821b-ccd892ae437a

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