FDA 483 - Lupin Limited - May 19, 2017

Lupin Limited, a drug manufacturer in Indore, India, received a Form 483 with six observations during an FDA inspection. The firm demonstrated significant quality control issues, including a high rate of invalidated Out-of-Specification results attributed to human error and inadequate investigation records. Further concerns were raised regarding insufficient written procedures for process controls, deficient batch records, poorly qualified stability chambers, and a lack of procedures for equipment maintenance.