FDA 483 - Dr. Reddy's Laboratories Limited CTO VI - January 28, 2020

Dr. Reddy's Laboratories Limited CTO Unit VI in Srikakulam District, India, received a Form 483 citing significant deficiencies in its manufacturing processes. The inspection revealed inadequate process validation, insufficient investigations into Out of Specification results, and poorly established cleaning validation procedures. Additionally, the firm failed to conduct trend analysis on APIs and demonstrated a lack of quality unit oversight for critical documents.