FDA 483 - H2 Beverages, Inc. - November 10, 2021

H2 Beverages, Inc. in Plano, TX, a beverage manufacturer, was cited for three observations during an FDA inspection. The firm lacked documentation for employee training and cGMP/hygiene SOPs. Additionally, the facility was not maintained in a clean and sanitary condition, evidenced by a hole in the ceiling near raw materials, and a cold storage unit used for raw materials lacked a temperature monitoring device.