FDA 483 - Jubilant Generics Limited - August 08, 2018

During an FDA inspection from July 30 to August 8, 2018, Jubilant Generics Limited, a drug product manufacturer located in Sikanderpur Bhainswal, India, received a Form FDA 483 listing significant observations related to its quality systems. Key issues included a failure to thoroughly review unexplained discrepancies and batch failures, specifically regarding the use of an unapproved excipient in multiple batches of Valsartan Tablets destined for the U.S. and E.U. markets. Despite identifying this issue in December 2017 and receiving market complaints, the company's investigation was incomplete, and Field Alert Reports for ten additional affected U.S. batches were substantially delayed by several months.

Furthermore, the firm was cited for inadequate investigation records for drug complaints, particularly concerning Pantoprazole Delayed Release Tablets, where numerous quality complaints were received but reserve samples were not consistently checked as per internal procedures, and recall classifications were not re-evaluated despite ongoing issues. The inspection also found a failure to follow written procedures for in-process controls, as a crucial test for other tablet products was not re-introduced after assay failures. These observations highlight systemic deficiencies in quality control, complaint management, and regulatory reporting, requiring comprehensive corrective and preventive actions from Jubilant Generics Limited to ensure product quality and compliance with regulatory standards.