# FDA 483 - Clinogent (A Division of GVK Biosciences Pvt. Ltd.) - October 09, 2014

Source: https://www.keypedia.com/records/483/clinogent-a-division-of-gvk-biosciences-pvt-ltd/32a0af5f-efc6-45bf-842d-33b5591b0c80

> FDA 483 for Clinogent (A Division of 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: Clinogent (A Division of GVK Biosciences Pvt. Ltd.)
- Inspection Date: 2014-10-09
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA Form 483 was issued to Clinogent (A Division of GVK Biosciences Pvt. Ltd.), a Clinical & Analytical Contract Research Organization (CRO) located in Hyderabad, India, following an inspection conducted from September 29 to October 9, 2014. The inspection revealed significant deviations from regulatory expectations, particularly concerning Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards for bioequivalence studies. The primary issues observed included systemic failures related to Standard Operating Procedures (SOPs). Specifically, the company demonstrated inadequate adherence to SOPs for archiving study records, with delays of up to nine months and the discovery of unarchived raw data from multiple years in analytical lab areas. Furthermore, accountability procedures for "controlled" study forms were not consistently followed, leading to incomplete reconciliation. Additionally, the inspection identified deficiencies in maintaining accurate and complete clinical study records. This included an incorrect subject registration number documented on an Electrocardiogram (ECG) and discrepancies between logbooks regarding sample processing and freezing times, indicating potential data integrity issues. A critical finding was the improper documentation of informed consent; a study-specific screening consent form used for additional blood sampling was not submitted to or approved by the Ethics Committee, undermining the ethical oversight of participant safety and rights. Clinogent is required to promptly address these serious observations, implement comprehensive corrective and preventive actions, and ensure full compliance with regulatory requirements to prevent recurrence of these deficiencies.

## Related Officers

- [Senior Advisor, Office of Study Integrity and Surveillance](https://www.keypedia.com/people/sam-haidar/658889fd-f946-4811-b3f5-7651cc6ce660)
- [Senior Vice President](https://www.keypedia.com/people/chetan-tamhankar/b0db5814-a278-43b9-814a-a0e88fed75ed)
- [investigator](https://www.keypedia.com/people/scott-b-laufenberg/ff95c69f-5ee2-4761-b4ef-8b8137c3d963)

Company: https://www.keypedia.com/companies/clinogent-a-division-of-gvk-biosciences-pvt-ltd/baba8f78-4e69-4a5d-8e7a-f44a00d0978b

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c