Lupin Limited – FDA 483, Feb 8, 2019

Lupin Limited in Verna, India, was cited with a Form 483 following an FDA inspection from January 28 to February 8, 2019. The inspection revealed significant deficiencies in the firm's quality control, including a failure to thoroughly investigate out-of-specification results and product defects before releasing drug products to the U.S. market. Additionally, the firm lacked adequate written procedures for critical production and process controls, leading to unvalidated manufacturing steps and unrecorded deviations.