FDA 483 - Outlook Group LLC - May 15, 2025

Outlook Group LLC, a repackager in Neenah, WI, received a Form FDA 483 with four observations during an inspection. The firm was cited for significant deficiencies including a lack of written procedures and proper oversight by the quality control unit, inadequate GMP training for employees, and insufficient controls over computer systems. Additionally, the firm failed to establish complete process validation records for its packaging lines, indicating potential risks to drug product quality and data integrity.