FDA 483 - Health Plus Incorporated - October 20, 2018

Health Plus Incorporated, a manufacturer of pharmaceutical and dietary supplements in Chino, CA, was cited for numerous significant deficiencies during an FDA inspection. The firm failed to establish and adhere to specifications for components and finished products, did not adequately qualify suppliers, and exhibited issues with quality control, employee training, and stability testing. Several observations were repeats from previous inspections, indicating persistent non-compliance.