FDA 483 - RA Chem Pharma Limited

An FDA inspection of RA Chem Pharma Limited, a bioequivalence testing facility in Hyderabad, India, revealed significant deficiencies in both clinical and bioanalytical study practices. Observations included failures in maintaining test article integrity, inaccurate data recording, and inadequate documentation and control over analytical processes. These issues indicate a lack of robust controls over study integrity and data accuracy.