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