FDA 483 - Distributor RFR, LLC. - June 14, 2024

The Food and Drug Administration (FDA) issued a Form 483 to a dietary supplement firm following an inspection conducted from June 2, 2022, to June 14, 2022. The inspection revealed significant deficiencies in the company's quality control and operational procedures, primarily concerning a specific dietary supplement product. A major observation was the absence of quality control personnel to oversee contracted manufacturing, packaging, and labeling operations for the dietary supplement prior to importation. This critical lapse meant the firm could not ensure the product met specifications for identity, purity, strength, composition, or contamination limits.

Further findings included the failure to establish product specifications for the finished dietary supplement, as well as a lack of written procedures for its manufacturing, packaging, and labeling. Additionally, the firm had not developed essential written procedures for holding and distributing the product, for reviewing and investigating product complaints, or for handling returned dietary supplements. These observations indicate a need for the firm to implement robust quality control measures, establish comprehensive product specifications, and develop and adhere to written procedures for all critical operations, in compliance with federal regulations for dietary supplements. The company is required to respond to these findings with a plan for corrective actions.