FDA 483 - G&N Enterprise, LLC - March 22, 2019

G&N Enterprise, LLC, an own label distributor in Jackson, MS, was inspected by the FDA, revealing significant deficiencies. The inspection cited a lack of established written procedures and proper oversight across its quality control unit, labeling, complaint handling, warehousing, recall processes, GMP training, and facility maintenance. These observations indicate a broad failure to comply with good manufacturing practices for drug product manufacturing, storage, and distribution.