Lupin Plant Draws FDA Warning Letter for Cleaning and Contamination Issues

The FDA handed Lupin a warning letter citing the company’s failure to correct cross-contamination issues noted in an inspection of its manufacturing plant in Palghar, India, earlier this year.

During the March 22 to April 4 inspection, the agency’s investigator noted multiple deficiencies in the company’s risk assessment, cleaning procedures and monitoring activities, including inadequate procedures to minimize the risk of contamination.

In response to the inspection observations, the company told the FDA that it would restrict the manufacture of one product and an active pharmaceutical ingredient to dedicated equipment. But the agency noted that solvent recovery tanks were still shared and the cross-contamination risks remained.

In the warning letter, the FDA required Lupin to provide a detailed plan for correcting the problems, including “a comprehensive, independent retrospective assessment” of its cleaning procedure effectiveness and a corrective and preventive action (CAPA) plan to improve its cleaning validation program.