FDA 483 - Lofty Laboratories Private Limited - August 04, 2022

An FDA inspection of Lofty Laboratories Private Limited in Pashamylaram, India, revealed significant deficiencies in laboratory controls and quality systems. The firm failed to adequately investigate unexplained discrepancies, including HPLC system suitability failures and column leakages. Additionally, their HPLC test methods for intermediate drug substances lacked established system suitability runs prior to analysis.