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

An FDA inspection of Be Powerful, LLC, doing business as BPI Sports, a dietary supplement own label distributor located in Fort Lauderdale, FL, was conducted from August 12 to September 7, 2021. The surveillance inspection, performed under 21 CFR Part 111 (Dietary Supplements Good Manufacturing Practices), identified several significant violations. The firm failed to establish comprehensive product specifications for the identity, purity, strength, and composition of its finished dietary supplements, and also lacked established packaging and labeling specifications. A critical issue noted was the absence of documented quality control operations for approving or rejecting packaged and labeled dietary supplements prior to their release for distribution. The inspection also revealed that the company did not consistently follow its written procedures for reviewing and investigating consumer complaints, with records often missing essential information such as investigation findings or follow-up actions. Other concerns included a missing allergen statement on a product label (CLA+ Carnitine), inconsistencies in warehouse temperature and humidity monitoring, and discrepancies between a product's batch record and its label ingredients for Keto Weight Loss. Furthermore, the firm lacked a written recall procedure. Management committed to addressing these observations and providing a written response within 15 business days, acknowledging potential regulatory actions for non-compliance.