FDA 483 - Genus Lifesciences Inc. - September 20, 2019

Genus Lifesciences Inc. in Allentown, PA, was cited for significant deficiencies in its quality control systems during an FDA inspection. The firm failed to thoroughly investigate product discrepancies, including cloudiness, empty bottles, and mold contamination, and lacked adequate written procedures for production and process controls, particularly for packaging validation. Additionally, the company did not submit a required Field Alert Report within the specified timeframe for a significant product issue.