FDA EIR - Lupin Ltd. - April 17, 2017

An FDA cGMP and pre-approval inspection of Lupin Limited in Aurangabad, Maharashtra, India, was conducted from April 19-25, 20XX, in response to a CDER request for Atovaquone Oral Suspension. The inspection followed 21 CFR Part 211 and the Federal Food, Drug, and Cosmetic Act. The facility manufactures various drug products for the U.S. market, including Amlodipine Besylate Tablets and Levetiracetam Oral Solution. The inspection identified eight observations on an FDA Form 483. Key issues included the inadequate investigation of market complaints, particularly the failure to extend investigations to other batches and insufficient documentation of visual inspections of retention samples (e.g., concerning hair on tablets and glass in bottles). Other violations involved the absence of a written procedure for reviewing stored in-process test data, an inadequate system for controlling contamination in processing equipment, and the lack of microbial contamination testing for primary drug product containers upon receipt. Additionally, personnel attire was deemed inappropriate, drug product contact surfaces were not consistently cleaned or sanitized, and temperature/humidity data in processing areas lacked reliability. Effectiveness testing for a commercial product was also not performed at shelf-life end. Lupin Limited's management committed to addressing all deficiencies and stated they would provide a written response to the FDA within 15 business days, outlining their corrective actions.