FDA 483 - Bulletproof 360 Inc - September 06, 2019

Bulletproof 360 Inc. in Seattle, WA, an own label distributor of dietary supplements and conventional food, was cited for significant quality control failures. The inspection revealed a lack of established specifications for both raw materials and finished products, a failure to properly investigate numerous serious adverse event and adverse reaction complaints, and inadequate production and process controls, including issues with contract manufacturer qualification and allergen control. Furthermore, the firm lacked a proper supply-chain program, highlighted by a Class I recall for Listeria contamination in protein bars and a mislabeled dietary supplement recall.