FDA 483 - Unipharm Inc. - November 21, 2025

Unipharm Inc., a repackager in Waterbury, CT, was cited for significant deficiencies in its quality control and production processes. The inspection revealed failures in validating packaging processes and equipment, accurately determining packaging yields due to undocumented reprocessing, and adhering to internal SOPs for managing quality events. These issues indicate a systemic breakdown in ensuring drug product quality and compliance.