FDA 483 - Pathogenes, Inc. - April 24, 2019

Pathogenes, Inc. in Reddick, FL, an own-label distributor of prescription drug products, was cited for significant deficiencies in its quality system during an FDA inspection. The firm lacked a quality control unit, proper procedures for labeling, sampling, warehousing, and distribution of its drug products Orogln and NeuroQuel. These issues indicate a severe lack of cGMP compliance across multiple critical areas.