FDA 483 - Sweet"s Syrup - August 22, 2024

Sweet's Elderberry LLC, an acidified dietary supplement manufacturer in Charlotte, NC, was cited for significant deficiencies across its manufacturing and quality control systems. Observations included failures in process control for elderberry products, inadequate record-keeping for product distribution and batch production, and a lack of established specifications for finished products and raw materials. The firm also lacked written quality control procedures and failed to qualify its suppliers.