FDA EIR - Be Powerful, LLC - May 17, 2017

An FDA inspection of Bpi Sports, Llc, a dietary supplement warehouse and distributor in Hollywood, FL, was conducted from May 9 to May 17, 2017. This initial inspection, performed under the dietary supplements regulatory framework, focused on compliance related to products like RoxyLean and Best Test .The inspection revealed two primary violations. First, the company lacked adequate documentation to qualify the contract manufacturer of its finished dietary supplement, RoxyLean , indicating a failure to establish the reliability of the supplier's certificates of analysis. Second, Bpi Sports failed to follow its own written procedures for incoming product inspection regarding a RoxyLean shipment, as evidenced by the absence of a physical examination before partial distribution. These observations highlighted non-compliance with established quality control practices. Mr. Vincent Annunziata, the company's Compliance Officer, acknowledged the findings and committed to implementing corrective actions. A formal written response outlining these actions was required to be submitted to the FDA within 15 business days.