FDA 483 - Be Powerful, LLC - May 17, 2017

BPI Sports, Llc in Hollywood, FL, an own-label dietary supplement distributor, was cited for two observations during an FDA inspection. The firm failed to qualify a supplier for a component of their RoxyLean dietary supplement and did not follow written procedures for holding and distributing operations, leading to partial distribution of product before physical examination. These issues indicate deficiencies in quality control and adherence to established procedures.