FDA 483 - Raptim Research Pvt. Ltd. - April 24, 2023

Raptim Research Private Limited, a Contract Research Organization in Navi Mumbai, India, was cited for significant deficiencies in its bioanalytical studies. Observations included unjustified rejection and repetition of analytical runs, improper calculation of internal standard peak areas, and inadequate accountability of biological samples. The firm also failed to contemporaneously document investigations and include all relevant data in method validation statistics, indicating serious data integrity and quality control issues.