FDA 483 - Nature's Sunshine Products, Inc. - July 25, 2025

An FDA Form 483 was issued to Nature's Sunshine, a dietary supplement manufacturer in Spanish Fork, UT, following an inspection conducted from July 21-25, 2025. The document outlines significant observations regarding quality control, manufacturing processes, and record-keeping, indicating deviations from established procedures. A primary observation concerned the approval and release of the "Blood Stimulator" dietary supplement (Lot#001511671) that did not meet its finished product specifications, specifically regarding the capsule type. Despite updated product specifications, the Master Manufacturing Record (MMR) was not revised, leading to the use of an incorrect capsule type. Quality Assurance personnel approved and released this non-conforming batch for distribution, failing to reject a product that did not meet its own standards. Further issues included inadequate record-keeping. An incorrect batch number was initially entered for "Fat Grabbers" (Lot#001652603) in the Batch Production Record and later corrected without proper contemporaneous documentation. Additionally, Quality Assurance Management did not document material review and disposition decisions at the time they were performed. These observations are issued under the Federal Food, Drug, and Cosmetic Act, highlighting the need for the company to review and improve its quality management system to ensure product quality and accurate manufacturing documentation. The company is expected to address these findings and implement appropriate corrective actions.