FDA 483 - Zarbee's Inc - June 17, 2015

Zarbee's, Inc., a dietary supplement own label distributor in Draper, UT, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to report serious adverse events associated with its dietary supplements to the FDA via MedWatch and did not properly investigate numerous product complaints, including those involving children requiring medical treatment. Additionally, the company did not follow its own written procedures for complaint handling and lacked documentation for the qualification of its product manufacturers.