FDA 483 - Be Powerful, LLC - September 07, 2021

An FDA inspection of Be Powerful, LLC, an own label distributor of dietary supplements in Fort Lauderdale, FL, revealed significant deficiencies in quality control and complaint handling. The firm failed to establish product and packaging specifications, lacked proper quality control release procedures for finished products, and did not follow written procedures for reviewing and investigating product complaints. These issues indicate a lack of adequate controls over the firm's dietary supplement operations.