Lupin Ltd. – FDA 483, Apr 26, 2017

An FDA Current Good Manufacturing Practice (cGMP) and pre-approval inspection of Lupin Ltd., located in Aurangabad, Maharashtra, India, was conducted from April 17 to April 26, 2017. The inspection, which covered various drug products including Atovaquone Oral Suspension and Amlodipine Besylate tablets, identified eight significant observations of non-compliance with 21 CFR Part 211 regulations. Key issues included the inadequate investigation of market complaints, where problems like foreign particles were not thoroughly extended to other batches or properly documented. The firm lacked a written procedure to review all stored data from in-process testing equipment, raising data integrity concerns. Significant contamination control deficiencies were observed, with dirty manufacturing filters posing a risk of microbial contamination, and primary drug product containers not tested for microbial contamination upon receipt. Gowning procedures were not consistently followed by personnel, and drug product contact surfaces were not always cleaned or sanitized. Reliability of temperature and humidity data in critical processing areas was compromised due to unaddressed equipment malfunctions. Lastly, the effectiveness of preservatives in Levetiracetam oral solution was not evaluated at the end of its shelf life, and changes in preservative content were not justified. Lupin Ltd. management committed to addressing all deficiencies and providing a written response to the FDA within 15 business days.