FDA 483 - Pure Simple Products aka Northern Elderberry - February 27, 2025

Pure Simple Products, also known as Northern Elderberry, a dietary supplement manufacturer in Traverse City, MI, was cited for significant deficiencies during an FDA inspection. The inspection revealed issues across multiple areas, including incomplete batch production records, a lack of established product specifications for purity, and a failure to collect representative finished product samples. Additionally, the firm lacked written procedures for handling returned dietary supplements, indicating a broad need for improved quality control and documentation practices.