# FDA 483 - ClinSync Clinical Research Pvt Ltd - October 24, 2025

Source: https://www.globalkeysolutions.net/records/483/clinsync-clinical-research-pvt-ltd/7d70048e-ab29-4761-8419-4f796e9f7d11

> FDA 483 for ClinSync Clinical Research Pvt Ltd on October 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ClinSync Clinical Research Pvt Ltd
- Inspection Date: 2025-10-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of ClinSync Clinical Research Pvt Ltd in Hyderabad, Telangana, India, revealed significant deficiencies in their conduct of bioequivalence studies. The firm failed to adhere to Good Clinical Practice, including making post-hoc modifications to analysis approaches and retrospectively documenting numerous protocol deviations without proper impact assessments. Additionally, the firm could not provide complete archived email communications necessary to reconstruct study activities.

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## Related Officers

- [Scott N. Lim](https://www.globalkeysolutions.net/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)
- [Melkamu Getie Kebtie](https://www.globalkeysolutions.net/people/melkamu-getie-kebtie/e7c26e5f-2f7f-46ad-83bc-09006f3cdc26)

Company: https://www.globalkeysolutions.net/companies/clinsync-clinical-research-pvt-ltd/9443aac7-d0a8-4a05-87f4-e085f3d21415

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8