FDA 483 - Manna Omni International, Inc. - September 24, 2020

Manna Omni International, Inc. in Fullerton, CA, an own label distributor, was cited for significant deficiencies in its laboratory control system during an FDA inspection. The firm failed to ensure appropriate finished product testing for its TheraDerm Pain Relieving Patch prior to release and lacked adequate stability data to support the product's expiration dating and storage conditions. These issues indicate a failure in quality control and data integrity practices.