FDA 483 - Sweet's Elderberry LLC - August 22, 2024

An FDA inspection conducted at Sweet's Elderberry LLC from August 20-22, 2024, revealed significant deviations from regulatory requirements for acidified dietary supplement manufacturing. The Charlotte, NC-based company received an FDA Form 483 listing eight observations.

Key issues included failures in process control, where batches of Elderberry Extract and Syrup did not consistently meet required temperature parameters during filling, posing potential public health risks. The firm also lacked comprehensive records for initial product distribution, hindering traceability, especially for smaller bottle sizes. Additionally, Sweet's Elderberry LLC had not established critical quality standards, such as product specifications for identity, purity, strength, and contamination limits for both finished dietary supplements and their raw components.

Master Manufacturing Records and Batch Production Records were found to be incomplete or inaccurate, lacking essential details like theoretical yields, equipment identification, monitoring results, and proper quality control review. The inspection also noted the absence of written procedures for various quality control operations, including laboratory functions, manufacturing, packaging, labeling, and handling of complaints or returns. Finally, the company did not adequately qualify its suppliers by verifying the reliability of Certificates of Analysis for incoming components.

To address these observations, Sweet's Elderberry LLC is required to implement comprehensive corrective actions to ensure compliance with federal food and dietary supplement regulations, thereby safeguarding product quality and consumer safety.