FDA 483 - Health Plus Incorporated - July 01, 2021

An FDA inspection of Health Plus Incorporated in Chino, CA, revealed significant deficiencies in the manufacturing of their Super Colon Cleanse Laxative drug product. The firm exhibited widespread non-compliance with GMP regulations, including failures in quality unit investigations, employee training, change control, component rejection, laboratory controls, stability testing, and process validation. Several critical observations were repeats from a previous 2018 inspection, indicating persistent issues.