FDA 483 - Distributor RFR, LLC. - June 14, 2022

An FDA inspection of Distributor RFR, LLC. in Doral, FL, a dietary supplement distributor, revealed significant deficiencies in their quality control system. The firm failed to ensure quality control over contracted manufacturing, packaging, and labeling operations, and lacked essential written procedures for product specifications, holding, distribution, complaint handling, and returned products. These issues indicate a systemic failure to comply with regulatory requirements for dietary supplement distribution.